Apparatus and methods for treating rhinitis

ABSTRACT

Apparatus and methods for treating conditions such as rhinitis are disclosed herein where a distal end of a probe shaft is introduced through the nasal cavity where the distal end has an end effector with a first configuration having a low-profile which is shaped to manipulate tissue within the nasal cavity. The distal end may be positioned into proximity of a tissue region having a post nasal nerve associated with a middle or inferior nasal turbinate. Once suitably positioned, the distal end may be reconfigured from the first configuration to a second configuration which is shaped to contact and follow the tissue region and the post nasal nerve may then be ablated via the distal end. Ablation may be performed using various mechanisms, such as cryotherapy, and optionally under direct visualization.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/884,547 filed Sep. 30, 2013 and 62/015,468 filed Jun. 22, 2014,each of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention is related to devices and methods for ablatingregions of tissue. More particularly, the present invention is relatedto devices and methods for ablating regions of tissue such as throughcryogenic ablation of tissue regions within the nasal cavity fortreating conditions such as rhinitis.

BACKGROUND OF THE INVENTION

The human nose is responsible for warming, humidifying and filteringinspired air. The nose is mainly formed of cartilage, bone, mucousmembranes and skin. The right and left nasal cavities extend back to thesoft palate, where they merge to form the posterior choanae. Theposterior choanae opens into the nasopharynx. The roof of the nose isformed, in part, by a bone known as the cribriform plate. The cribriformplate contains numerous tiny perforations through which sensory nervefibers extend to the olfactory bulbs. The sensation for smell occurswhen inhaled odors contact a small area of mucosa in the superior regionof the nose, stimulating the nerve fibers that lead to the olfactorybulbs.

The nasal turbinates are three bony processes that extend inwardly fromthe lateral walls of the nose and are covered with mucosal tissue. Theseturbinates serve to increase the interior surface area of the nose andto impart warmth and moisture to air that is inhaled through the nose.The mucosal tissue that covers the turbinates is capable of becomingengorged with blood and swelling or becoming substantially devoid ofblood and shrinking, in response to changes in physiologic orenvironmental conditions. The curved edge of each turbinate defines apassage way known as a meatus. For example, the inferior meatus is apassageway that passes beneath the inferior turbinate. Ducts, knows asthe nasolacrimal ducts, drain tears from the eyes into the nose throughopenings located within the inferior meatus. The middle meatus is apassageway that extends inferior to the middle turbinate. The middlemeatus contains the semilunar hiatus, with openings or Ostia leadinginto the maxillary, frontal, and anterior ethmoid sinuses. The superiormeatus is located between the superior and medial turbinates.

The turbinates are autonomically innervated by nerves arising from theVidian nerve which contains sympathetic and parasympathetic afferentsthat can modulate the function of the turbinates to either increase(parasympathetic) or decrease (sympathetic) activity of the submucosallayer. The pterygoid canal carries both parasympathetic and sympatheticfibers, namely the vidian nerve, to the sphenopalatine ganglion.Exclusive of the sphenopalatine foramen (SPF) contents, additionalposterolateral neurovascular rami project from the sphinopaletineganglion via multiple individual postganglionic rami to supply the nasalmucosa. The most common locations for these rami are within 1 cmposterosuperior to the horizontal attachment of the inferior turbinate,within 5 mm anteroinferior to this attachment, and the palatine bone viaa foramen distinct from the SPF. Also, Blier, et. al showed thatinterfascicle anastomotic loops in some cases, are associated with atleast 3 accessory nerves. Based on Blier et. al work each accessorynerve could be proximally traced directly to the PPG or greater palatinenerve.

Rhinitis is defined as inflammation of the membranes lining the nose,characterized by nasal symptoms, including itching, rhinorrhea, and/ornasal congestion. Chronic Rhinitis affects tens of millions of people inthe US and is a leading cause for patients to seek medical care. Medicaltreatment has been shown to have limited effects for chronic rhinitissufferers and requires daily medication use or onerous allergytreatments and up to 20% of patients may be refractory.

In addition to the medications turbinate reduction surgery (RF andmicro-debridement) both have temporary duration of effect of 1-2 yearsand can result in complications including mucosal sloughing, acute painand swelling, overtreatment and bone damage. Additionally, turbinatereduction does not treat the symptom of rhinorrhea. It is thought thatparasympathetic effect of the vidian nerve predominates so that, ontransecting it, the result is decreased rhinitis and congestion. Thispathophysiology has been confirmed as surgical treatment of the vidiannerve has been tried with great success; however, the procedure isinvasive, time consuming and potentially can result in dry eyes due toautonomic fibers in the vidian nerve that supply the lacrimal glands.

Golding-Wood, who recommended cutting the parasympathetic nerve fibersin the vidian canal to decrease the parasympathetic tone to the nasalmucosa, introduced a different approach for the treatment ofhypersecretion in 1961. Various approaches to the vidian canal weresubsequently developed, and the method was widely employed in the 1970s.However, the original technique was abandoned at the beginning of the1980s because of its irreversible complications such as dry eyes.

Recent studies have shown that selectively interrupting the Post NasalNerves (PNN) in patients with chronic rhinitis improves their symptomswhile avoiding the morbidities associated with vidian neurectomy.¹ Thestudy by Ikeda et. al suggests that the effect of an anticholinergicdrug on nasal symptoms resembled that of PNN resection in patients withchronic rhinitis. Based on his study the glandular mucosal acinar cellswere significantly reduced after the PNN resection. The reduction inglandular cells may be explained by decreased secretion of the nervegrowth factor or epidermal growth factor regulated by acetylcholine, amajor neurotransmitter of parasympathetic systems.

Posterior nasal neurectomy, initially developed by Kikawada in 1998 andlater modified by Kawamura and Kubo, is an alternative method in whichneural bundles are selectively cut or cauterized from the sphenopalatineforamen. Autonomic and sensory nerve fibers that pass through theforamen anatomically branch into the middle and inferior turbinate andare distributed around the mucosal layer of the nose. Therefore,selective neurectomy at this point enables physicians to theoreticallyavoid surgical complications such as inhibition of lacrimal secretion.

SUMMARY OF THE INVENTION

The Posterior Nasal Nerves (PNN) innervate, inferior, middle, andinferior turbinates. Ablating these nerves leads to a decrease in orinterruption of parasympathetic nerve signals that contribute tocongestion and rhinorrhea in patients with chronic rhinitis (allergic orvasomotor). The devices and methods described herein are configured tobe used for ablating one or more of these branches to reduce oreliminate rhinitis, e.g., ablating the Posterior Nasal Nerves (PNN).

Generally, several various apparatus and methods may be used to ablatethe PNN as described below. One method for treating the tissue regionwithin a nasal cavity in proximity to the PNN may be comprised ofintroducing a distal end of a probe shaft through the nasal cavity,wherein the distal end has an end effector with a first configurationhaving a low-profile which is shaped to manipulate tissue within thenasal cavity. The distal end may be positioned into proximity of thetissue region having the PNN associated with a middle or inferior nasalturbinate. Once suitably positioned, the distal end may be reconfiguredfrom the first configuration to a second configuration, which is shapedto contact and follow the tissue region. The distal end may then be usedto ablate the PNN within the tissue region utilizing a number ofdifferent tissue treatment mechanisms, e.g., cryotherapy, as describedherein.

In treating the tissue region in one variation, the distal end may bepositioned specifically into proximity of the tissue region which issurrounded by the middle nasal turbinate, inferior nasal turbinate, andlateral wall forming a cul-de-sac and having the PNN associated with themiddle or inferior nasal turbinate. The distal end may be reconfiguredto treat the tissue region accordingly.

Various configurations for the distal end may be utilized in treatingthe tissue region so long as the distal end is configured for placementwithin the narrowed confines of the nasal cavity and more specificallywithin the confines of the cul-de-sac defined by the tissue regionsurrounding the middle nasal turbinate, inferior nasal turbinate, andlateral nasal tissue wall.

One example of a surgical probe configured for ablating the tissueregion within such narrowed confines includes a surgical probe apparatushaving a surgical probe shaft comprising an elongated structure with adistal end and a proximal end, an expandable structure attached to thedistal end of the probe shaft, the expandable structure having adeflated configuration and an expanded configuration. A lumen may bedefined through the shaft in fluid communication with an interior of theexpandable structure. A member may be attached to the distal end andextend within the expandable structure which encloses the member suchthat the member is unattached to the interior of the expandablestructure. Moreover, the member may define an atraumatic shape, which issized for pressing against and manipulating through the expandablestructure the lateral nasal wall or other tissue proximate to the PNN.

An example of utilizing such a structure in treating the tissue regionmay generally comprise advancing the distal end of the surgical probeshaft through the nasal cavity and into proximity of the tissue regionhaving PNN associated with a middle or inferior nasal turbinate andintroducing a cryogenic fluid into the expandable structure attached tothe distal end of the probe shaft such that the expandable structureinflates from a deflated configuration into an expanded configurationagainst the tissue region.

As described above, a position of the member relative to the tissueregion may be adjusted where the member is attached to the distal end ofthe probe shaft and extends within the expandable structure, whichencloses the member such that the member is unattached to an interior ofthe expandable structure. The practitioner may apply a pressure againstthe distal end such that the member is pressed against the interior ofthe expandable structure which in turn is pressed against the tissueregion having the PNN, wherein the member defines an atraumatic shapewhich is sized for pressing against and manipulating the tissue region.The member may be maintained against the interior of the expandablestructure and the tissue region until the tissue region is cryogenicallyablated.

Any of the ablation devices herein can be used to ablate a single nervebranch or multiple nerve branches.

One aspect of this invention is a surgical probe configured for ablatingthe posterior nasal nerve associated with a nasal turbinate. Thesurgical probe, in one example, comprises a surgical shaft with aproximal end and a distal end, a surgical hand piece disposed on theproximal end, and a coiled spring-like structure disposed on the distalend. The coiled spring-like structure is a hollow structure comprising aclosely pitched wire coil forming a central lumen, and an outer surface.The surgical hand piece comprises a pressurized liquid cryogen reservoirand a user actuated liquid cryogen flow control valve. There is at leastone liquid cryogen path through the probe shaft in fluidic communicationwith the liquid flow control valve within the hand piece, and thespring-like coiled structure.

The pressurized cryogen liquid reservoir contains a liquid cryogen,e.g., nitrous oxide, but may also be another cryogenic liquid such asliquid carbon dioxide, or a liquid chlorofluorocarbon compound, etc. Thedistal spring-like structure may be configured as a liquid cryogenevaporator, either as a closed liquid cryogen evaporator, or as an openliquid cryogen evaporator.

In the closed evaporator configuration the inner central lumen of thespring-like structure is lined with a polymeric liner. Liquid cryogen isintroduced into the central lumen through liquid cryogen supply linethat is connected to the liquid cryogen reservoir in the handle, andruns coaxially through the probe shaft. The evaporated liquid cryogenmay be vented to the room, e.g., through the probe shaft to a vent portin the hand piece, or in the vicinity of the proximal end of the probeshaft. No liquid or gas cryogen is introduced into the patient's nasalcavity.

In the open liquid cryogen evaporator configuration, the evaporatedcryogen may exit the central lumen of the spring-like structure betweenthe wire coils, and into the nasal cavity of the patient. Precautions toprevent the patient from inhaling the cryogen gas may be taken. As anexample, a distal occlusion balloon may be used to occlude the distalnasal passageway.

The surgical probe may be configured so that the surgeon can press thedistal spring like structure against the lateral nasal wall proximate tothe target posterior nasal nerve. The spring-like structure isconfigured to conform to the morphology of the lateral nasal wall and toevenly engage the lateral nasal wall with a substantially uniformcontact pressure. The probe shaft may have a length between, e.g.,approximately 4 cm and 10 cm, and a diameter between, e.g.,approximately 1 mm and 4 mm. The distal spring-like structure may havean outer diameter that approximates the diameter of the probe shaft, ormay be larger or smaller in diameter. The extended length of thespring-like structure may be between, e.g., approximately 0.5 cm and 1.5cm.

The surgical probe may be supplied with the distal spring-like structureconfigured straight and coaxial with the probe shaft. In anotherembodiment, the distal spring like structure is supplied with a lateralcurve with the proximal end of the spring-like structure in a tangentialrelationship with the distal end of the probe shaft. In anotherembodiment, the surgical probe may be supplied with the distalspring-like structure in a loop configuration where both ends of thespring-like structure are in a substantially tangential relationshipwith the distal end of the probe shaft.

The distal spring-like structure is substantially flexible along itsaxis; however, the structure may also be at least partly malleable andconfigured for form shaping by the user. Form shaping of the spring-likestructure may be done manually by the surgeon, or alternatively thesurgical probe may be supplied with the distal spring like structure invarious predetermined/factory configurations. Various lengths, shapes,and diameters of the spring-like structure of the surgical probe may beproduced and supplied to the end user.

In one embodiment, the distal spring-like structure is configured as acryogenic liquid evaporator, where cryogenic liquid is delivered to thecentral lumen of the distal spring like structure. The liquid thenevaporates at a low temperature, which causes the outer surface of thespring-like structure to reach a temperature that is sufficiently coldto ablate surrounding tissue and the function of the target posteriornasal nerve. The surgical probe may be configured so that thetemperature of the outer surface of the spring-like structure is between−20 Deg. C. and −50 Deg. C. during liquid cryogen evaporation.

The surgical hand piece may comprise a factory filled liquid cryogenreservoir, and a user actuated cryogen flow control valve. The surgicalhand piece may be configured so that it is held by the user like apistol having a pistol grip where the cryogen flow valve actuator isconfigured like a pistol trigger. In an alternate embodiment, thesurgical hand piece is configured for the surgeon to grip itsubstantially like a writing utensil, with a button located in thevicinity of the index finger configured to actuate the cryogen flowcontrol valve. In a third embodiment, the surgical hand piece may beconfigured to be held by the surgeon substantially like a pistol or awriting utensil, with a pistol like trigger configured to actuate acryogen flow control valve, and a button in the vicinity of the indexfinger configured to actuate the same or a second cryogen control valve.

In another embodiment of this invention, the distal spring-likestructure is encompassed by an expandable membranous structure. Theexpandable membranous structure may be a hollow bulbous structure with asingle ostium configured for pressure tight bonding to the distal end ofthe probe shaft. The expandable membranous structure may be configuredas a liquid cryogen evaporation chamber. Liquid cryogen is introducedinto the expandable membranous structure from the encompassedspring-like structure.

The evaporated cryogen may be exhausted into the room through the probeshaft to a vent port in the hand piece, or in the vicinity of theproximal end of the probe shaft. The surgical probe is configured sothat the expandable membranous structure expands to a predeterminedshape in response to liquid cryogen evaporation. The pressure within theexpandable membranous structure during cryogen evaporation may beregulated. The regulation means may comprise a pressure relief valvedisposed in the gas exhaust path. The expandable membranous structuremay be formed from an elastomeric material such as silicone rubber, or aurethane rubber. Alternatively, the expandable membranous structure maybe formed from a substantially non-elastomeric material such aspolyurethane or PET. The expandable membranous structure is configuredso the shape and the size of the structure matches the shape and thesize of the cul-de-sac of the lateral nasal wall defined by the tail ofthe middle turbinate, lateral nasal wall and the inferior turbinate,which is the target location for the ablation of the posterior nasalnerves for the treatment of rhinitis. Matching the size and shape of theexpandable membranous structure to the size and shape of the targetanatomy facilitates optimal tissue freezing and ablation of posteriornasal nerves. The expandable to membranous structure may have anexpanded diameter between approximately 3 mm and 12 mm in one radialaxis, and may be configured such that the expanded diameter in oneradial axis is different than another radial axis.

The probe shaft may be straight and rigid, or alternatively may besubstantially malleable and configured for form shaping by the user. Theprobe shaft may be straight and rigid in the proximal region, andsubstantially malleable in the distal region and configured for formshaping by the user.

The surgical probe may be configured with a camera and a light sourcedisposed in the vicinity of the distal end of the probe shaft. Thecamera and light source may be configured to provide the surgeon withimages of the nasal anatomy in order to identify anatomical landmarksfor guiding the surgical placement of the distal spring-like structureagainst the lateral nasal wall proximate to the target posterior nasalnerve. The camera and light source may be further configured to imagetissue freezing to provide the surgeon with visual feedback on theprogress of a cryo-ablation of the nasal tissue innervated by posteriornasal nerves.

The surgical probe may also be configured with at least one temperaturesensor disposed in the vicinity of the distal end. The temperaturesensor may be configured to sense a temperature indicative of cryogenevaporation temperature, or a temperature indicative of a tissuetemperature of surgical interest. Signals from the at least onetemperature sensor may be used to servo-control the flow of cryogen inorder to control a tissue temperature or to control the evaporationtemperature. A temperature sensor may also be used in an informationaldisplay, or for system alarms or interlocks.

The surgical probe may be configured to automatically adjust the flowrate of liquid cryogen in response to one or more of the followingparameters: evaporator temperature, evaporator pressure, tissuetemperature, evaporator exhaust gas temperature, or elapsed cryogen flowtime. The flow rate may be adjusted in a continuous analog manner, or byan alternating on/off flow modulation.

Another aspect of this invention is a method for treating rhinitis byablating posterior nasal nerves associated with a middle or inferiornasal turbinate. The method may comprise inserting the distal end of asurgical probe configured for cryoneurolysis into a nostril of a patientwith the surgical probe comprising a hollow probe shaft that is, e.g.,to substantially rigid. The surgical hand piece disposed on the proximalend of the probe shaft may comprise a liquid cryogen reservoir and,e.g., a user actuated liquid cryogen flow control valve. A cryogenliquid evaporator comprising, e.g., a spring-like structure configuredas a liquid cryogen evaporator, may be disposed on the distal end of theprobe shaft. The distal spring-like structure may be positioned againstthe lateral nasal wall proximate to a target posterior nasal nerve andthen a flow of liquid cryogen to the spring-like structure may beactivated for a period of time sufficient to cryo-ablate a target areain the nose containing posterior nasal nerves.

The method may further involve the targeting of at least one additionalposterior nasal nerve, either within the ipsilateral nasal cavity, or aposterior nasal nerve in a contralateral nasal cavity.

The method may comprise the use of a surgical probe which has anexpandable membranous or non-membranous structure that encompasses thedistal spring-like structure and which is configured as an expandableliquid cryogen evaporation chamber. The expandable membranous structuremay be configured to be a predetermined size and shape that matches thesize and shape of the nasal wall anatomy proximate to the targetposterior nasal nerve. The surgical probe may be configured so theexpandable membranous structure expands to its predetermined size andshape in response to liquid cryogen evaporation within.

The method may comprise controlling the flow of the liquid cryogen intothe evaporation chamber based on at least one predetermined parameter,which may comprise one or more of the following parameters: cryogenicliquid flow rate, cryogenic liquid flow elapsed time, cryogenic liquidevaporation pressure, cryogenic liquid evaporation temperature,cryogenic gas exhaust temperature, visual determination of tissuefreezing, ultrasonic determination of tissue freezing, or the volume ofcryogenic liquid supplied by the cryogenic liquid reservoir.

The method may comprise determining the location of the target posteriornasal nerve, which may involve one or more of the following targetingtechniques: endoscopic determination based on the nasal anatomicallandmarks, electrical neuro-stimulation of the target posterior nasalnerve while observing the physiological response to the stimulation,electrical neuro-blockade, while observing the physiological response tothe blockade, or identification of the artery associated with the targetposterior nasal nerve using, e.g., ultrasonic or optical doppler flowtechniques.

Yet another aspect comprises an embodiment of a surgical probe which isconfigured for ablation where the surgical probe comprises a surgicalprobe shaft comprising an elongated structure with a distal end and aproximal end, an expandable structure attached to the distal end of theprobe shaft, the expandable structure having a deflated configurationand an expanded configuration, a member attached to the distal end andextending within the expandable structure such that the member isunattached to an interior of the expandable structure, wherein themember defines a flattened shape which is sized for placement against alateral nasal wall proximate to a posterior nasal nerve, and a lumen influid communication with the interior of the expandable structure.

In use, such a surgical probe may be used for treating a tissue regionwithin a nasal cavity, generally comprising advancing a distal end of asurgical probe shaft through the nasal cavity and into proximity of thetissue region having a posterior nasal nerve associated with a middle orinferior nasal turbinate, introducing a cryogenic liquid into anexpandable structure attached to the distal end of the probe shaft suchthat the expandable structure inflates from a deflated configurationinto an expanded configuration against the tissue region, positioning amember relative to the tissue region, wherein the member is attached tothe distal end of the probe shaft and extends within the expandablestructure such that the member is unattached to an interior of theexpandable structure, and wherein the member defines a flattened shapewhich is sized for placement against the tissue region proximate to theposterior nasal nerve, and maintaining the member against the tissueregion until the posterior nasal nerve is cryogenically ablated.

One aspect of the invention is a cryo-surgical probe apparatus forablation of PNN function comprising a handle at the proximal end, aprobe shaft with a spatula shaped cryo-ablation element mounted invicinity of the distal end of the shaft, whereby the handle isconfigured for housing a cryogen source, and controlling the flow of thecryogen to the cryo-ablation element, and the geometric parameters ofthe probe shaft and cryo-ablation element are optimally configured forcryo-ablation of nasal mucosa containing PNN according to the surgicalmethods disclosed here within.

One embodiment of this invention is a cryo-surgical probe apparatus forablation of nasal mucosa innervated by PNN comprise a handle at theproximal end, a probe shaft with a bullet shaped cryo-ablation elementmounted in vicinity of the distal end of the shaft, whereby the handleis configured for housing a cryogen source, and controlling the flow ofthe cryogen to the cryo-ablation element, and the geometric parametersof the probe shaft and cryo-ablation element are optimally configuredfor cryo-ablation of PNN according to the surgical methods disclosedhere within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN function comprising a handle at the proximal end, aprobe shaft with a bullet shaped cryo-ablation element mounted invicinity of the distal end of the shaft, whereby the handle isconfigured for housing a cryogen source, and controlling the flow of thecryogen to the cryo-ablation element, wherein the probe shaft isconfigured with user operable deflectable distal segment, and thegeometric parameters of the probe shaft and cryo-ablation element areoptimally configured for cryo-ablation of PNN according to the surgicalmethods disclosed here within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN comprising a handle at the proximal end, a probeshaft with a cylindrically shaped cryo-ablation element mounted invicinity of the distal end of the shaft, whereby the handle isconfigured for housing a cryogen source, and controlling the flow of thecryogen to the cryo-ablation element, wherein the cryo-ablation elementcomprises a linear segmented cryo-ablation element, and the geometricparameters of the probe shaft and cryo-ablation element are optimallyconfigured for cryo-ablation of PNN according to the surgical methodsdisclosed here within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN comprising a handle at the proximal end, a probeshaft with a cylindrically shaped cryo-ablation element mounted invicinity of the distal end of the shaft, whereby the handle isconfigured for housing a cryogen source, and controlling the flow of thecryogen to the cryo-ablation element, wherein the cryo-ablation elementcomprises a semi-circular cryo-ablation element, and the geometricparameters of the probe shaft and cryo-ablation element are optimallyconfigured for cryo-ablation of target tissue containing PNN accordingto the surgical methods disclosed here within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN function comprising a handle at the proximal end, aprobe shaft with a cylindrically shaped cryo-ablation element mounted invicinity of the distal end of the shaft, whereby the handle isconfigured for housing a cryogen source, and controlling the flow of thecryogen to the cryo-ablation element, wherein the cryo-ablation elementcomprises a spiraled cryo-ablation element, and the geometric parametersof the probe shaft and cryo-ablation element are optimally configuredfor cryo-ablation of target nasal tissue containing PNN according to thesurgical methods disclosed here within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN comprising a proximal end, a probe shaft with acryo-ablation element comprising a balloon mounted in vicinity of thedistal end of the shaft, whereby the proximal end is configured forreceiving a cryogen from a cryogen source with the cryogen sourcecomprising a means controlling the flow of the cryogen to thecryo-ablation element, and the geometric parameters of the probe shaftand cryo-ablation element are optimally configured for cryo-ablation ofPNN according to the surgical methods disclosed here within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN comprising a handle at the proximal end, a probeshaft with a cylindrically shaped cryo-ablation element comprising aballoon mounted in vicinity of the distal end of the shaft, whereby thehandle is configured for housing a cryogen source, and controlling theflow of the cryogen to the cryo-ablation element, and the geometricparameters of the probe shaft and cryo-ablation element are optimallyconfigured for cryo-ablation of target nasal tissue containing PNNaccording to the surgical methods disclosed here within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN comprising a handle at the proximal end, a probeshaft with a cylindrically shaped cryo-ablation element mountedcomprising a balloon with two lateral chambers disposed in the vicinityof the distal end of the shaft, whereby the handle is configured forhousing a cryogen source, and controlling the flow of the cryogen to thecryo-ablation element, wherein one chamber of the balloon is configuredas a cryogen expansion chamber, and the second chamber is configured asa thermal insulation chamber, and the geometric parameters of the probeshaft and cryo-ablation element are optimally configured forcryo-ablation of PNN according to the surgical methods disclosed herewithin.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN comprising a handle at the proximal end, a probeshaft with a “T” shaped cryo-ablation element comprising a balloonmounted in vicinity of the distal end of the shaft, whereby the handleis configured for housing a cryogen source, and controlling the flow ofthe cryogen to the cryo-ablation element, and the geometric parametersof the probe shaft and cryo-ablation element are optimally configuredfor cryo-ablation of PNN according to the surgical methods disclosedhere within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN function comprising a handle at the proximal end, aprobe shaft with a “J” shaped cryo-ablation element comprising a balloonmounted in vicinity of the distal end of the shaft, whereby the handleis configured for housing a cryogen source, and controlling the flow ofthe cryogen to the cryo-ablation element, and the geometric parametersof the probe shaft and cryo-ablation element are optimally configuredfor cryo-ablation of PNN according to the surgical methods disclosedhere within.

Another embodiment of this invention is a cryo-surgical probe apparatusfor ablation of PNN comprising a handle at the proximal end, a probeshaft with a cryo-ablation element mounted in vicinity of the distal endof the shaft, whereby the handle is configured for housing a cryogensource, and controlling the flow of the cryogen to the cryo-ablationelement, wherein a suction means associated with the cryo-ablationelement is configured for stabilizing the position of the cryo-ablationelement against the target tissue, and the geometric parameters of theprobe shaft and cryo-ablation element are optimally configured forcryo-ablation of PNN according to the surgical methods disclosed herewithin.

One aspect of this is a method for cryo-surgical ablation of PNNcomprising placing a film of oil or gel on the surface of acryo-ablation element, then pressing the cryo-ablation element againstthe lateral wall of a nasal cavity adjacent to a PNN, then ablating thefunction of the PNN with the cryo-ablation element, whereby the oil orgel prevents frozen nasal tissue from adhering to the cryo-ablationelement.

In another aspect of this invention is an electrosurgical probeapparatus for ablation of PNN comprising a handle at the proximal end, aprobe shaft with a radiofrequency (RF) ablation element comprising atleast one radiofrequency (RF) electrode mounted in the vicinity of thedistal end of the shaft, an electrical connector in the vicinity of thehandle configured to connect the RF ablation element to a source ofradiofrequency energy, whereby the geometric parameters of the probeshaft and RF ablation element are optimally configured for RF ablationof PNN function according to the surgical methods disclosed here within.

One embodiment of this invention is an electrosurgical probe apparatusfor ablation of PNN comprising a handle at the proximal end, a probeshaft with a radiofrequency (RF) ablation element comprising at leastone radiofrequency (RF) electrode mounted in the vicinity of the distalend of the shaft, an electrical connector disposed in the vicinity ofthe handle configured to connect the RF ablation element to a source ofradiofrequency energy, and a fluid connector disposed in the vicinity ofthe handle to connect at least one fluid port associated with the RFablation element with a source of pressurized liquid, whereby thegeometric parameters of the probe shaft and RF ablation element areoptimally configured for RF ablation of PNN according to the surgicalmethods disclosed here within.

Another embodiment of this invention is an electrosurgical probeapparatus for ablation of PNN comprising a handle at the proximal end, aprobe shaft with a radiofrequency (RF) ablation element comprising atleast one radiofrequency (RF) electrode mounted in the vicinity of thedistal end of the shaft, an electrical connector disposed in thevicinity of the handle configured to connect the RF ablation element toa source of radiofrequency energy, whereby the geometric parameters ofthe probe shaft and RF ablation element are optimally configured for RFablation of PNN according to the surgical methods disclosed here within,wherein the RF ablation element comprises a monopolar electrosurgicalconfiguration comprising one or more electrodes.

Another embodiment of this invention is an electrosurgical probeapparatus for ablation of PNN comprising a handle at the proximal end, aprobe shaft with a radiofrequency (RF) ablation element comprising atleast one radiofrequency (RF) electrode mounted in the vicinity of thedistal end of the shaft, an electrical connector disposed in thevicinity of the handle configured to connect the RF ablation element toa source of radiofrequency energy, whereby the geometric parameters ofthe probe shaft and RF ablation element are optimally configured for RFablation of PNN according to the surgical methods disclosed here within,wherein the RF ablation element comprises a bi-polar electrosurgicalconfiguration comprising two or more electrodes.

Another embodiment of this invention is an electrosurgical probeapparatus for ablation of PNN comprising a handle at the proximal end, aprobe shaft with a radiofrequency (RF) ablation element comprising atleast one radiofrequency (RF) electrode mounted in the vicinity of thedistal end of the shaft, an electrical connector disposed in thevicinity of the handle configured to connect the RF ablation element toa source of radiofrequency energy, whereby the geometric parameters ofthe probe shaft and RF ablation element are optimally configured for RFablation of PNN according to the surgical methods disclosed here within,wherein the RF ablation element is disposed in the vicinity of thedistal end of the shaft on a cylindrical, “J” shaped, “U” shaped or “T”shaped structure.

Another embodiment of this invention is an electrosurgical probeapparatus for ablation of PNN function comprising a handle at theproximal end, a probe shaft with a radiofrequency (RF) ablation elementcomprising at least one radiofrequency (RF) electrode mounted in thevicinity of the distal end of the shaft, an electrical connectordisposed in the vicinity of the handle configured to connect the RFablation element to a source of radiofrequency energy, whereby thegeometric parameters of the probe shaft and RF ablation element areoptimally configured for RF ablation of PNN according to the surgicalmethods disclosed here within, wherein the RF ablation element isconfigured in a lateral or radial arrangement.

Another embodiment of this invention is n electrosurgical probeapparatus for ablation of PNN function comprising a handle at theproximal end, a probe shaft with a radiofrequency (RF) ablation elementcomprising at least one radiofrequency (RF) electrode mounted in thevicinity of the distal end of the shaft, an electrical connectordisposed in the vicinity of the handle configured to connect the RFablation element to a source of radiofrequency energy, whereby thegeometric parameters of the probe shaft and RF ablation element areoptimally configured for RF ablation of PNN according to the surgicalmethods disclosed here within, wherein the RF ablation element comprisesa circular array of domed electrodes disposed on a flat electricallyinsulative surface, with the domed electrodes optionally associated witha fluid irrigation port.

Another embodiment of this invention is an electrosurgical probe forablation of PNN function comprising a handle at the proximal end, aprobe shaft with a radiofrequency (RF) ablation element comprising atleast one radiofrequency (RF) electrode mounted in the vicinity of thedistal end of the shaft, an electrical connector disposed in thevicinity of the handle configured to connect the RF ablation element toa source of radiofrequency energy, whereby the geometric parameters ofthe probe shaft and RF ablation element are optimally configured for RFablation of PNN according to the surgical methods disclosed here within,wherein the RF ablation element comprises a linear array of domedelectrodes disposed on a flat electrically insulative surface, with thedomed electrodes optionally associated with a fluid irrigation port, anda needle configured for injecting a liquid into a sub-mucosal space.

Another embodiment of this invention is an electrosurgical probeapparatus for ablation of PNN comprising a handle at the proximal end, aprobe shaft with a radiofrequency (RF) ablation element comprising atleast one radiofrequency (RF) electrode mounted in the vicinity of thedistal end of the shaft, an electrical connector disposed in thevicinity of the handle configured to connect the RF ablation element toa source of radiofrequency energy, whereby the geometric parameters ofthe probe shaft and RF ablation element are optimally configured for RFablation of PNN according to the surgical methods disclosed here within,wherein the RF ablation element comprises at least one needle configuredfor interstitial RF ablation.

Another embodiment of this invention is an electrosurgical probeapparatus for ablation of PNN comprising a handle at the proximal end, aprobe shaft comprising a distal and proximal end, and an integratedcircuit comprising an RF generator disposed in the vicinity of thehandle and an RF ablation element disposed in the vicinity of the distalend of the shaft, whereby the geometric parameters of the probe shaftand RF ablation element are optimally configured for RF ablation of PNNaccording to the surgical methods disclosed here within.

In another aspect of this invention is an ultrasonic energy emittingprobe apparatus for ablation of PNN comprising a handle at the proximalend, a probe shaft with an ultrasonic energy ablation element comprisingat least one ultrasonic energy emitter mounted in the vicinity of thedistal end of the shaft, an electrical connector in the vicinity of thehandle configured to connect the ultrasonic energy emitter to anultrasonic energy generator, whereby the geometric parameters of theprobe shaft and ultrasonic energy emitter are optimally configured forultrasonic energy ablation of PNN according to the surgical methodsdisclosed here within.

In another embodiment of this invention is an ultrasonic energy emittingprobe apparatus for ablation of PNN comprising a handle at the proximalend, a probe shaft with an ultrasonic energy ablation element comprisingat least one ultrasonic energy emitter mounted in the vicinity of thedistal end of the shaft, an electrical connector in the vicinity of thehandle configured to connect the ultrasonic energy emitter to anultrasonic energy generator; at least one fluid path in communicationbetween at least one fluid connector in the vicinity of the handle andthe ultrasonic energy emitter configured to cool the ultrasonic energyemitter during ultrasonic energy emission, whereby the geometricparameters of the probe shaft and ultrasonic energy emitter areoptimally configured for ultrasonic energy ablation of PNN according tothe surgical methods disclosed here within.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an internal lateral view of the nasal canal showing therelevant nasal anatomy and the targeted region of the lateral nasal wallfor cryo-ablation of posterior nasal nerve function.

FIG. 2 is a schematic illustration of a surgical probe configured forcryo-ablation of posterior nasal nerve function for the treatment ofrhinitis.

FIG. 3A is a view of the distal end of a surgical probe shaft with thespring-like structure coaxial to the surgical probe shaft.

FIG. 3B is a view of the distal end of a surgical probe shaft with thespring-like structure comprising a lateral curve in a tangentialrelationship with the surgical probe shaft.

FIG. 3C is a view of the distal end of a surgical probe shaft with thespring-like structure comprising a loop or a continuous structure.

FIG. 4A is a side view of the distal end of the surgical probe shaftwith the spring-like structure coaxial to the surgical probe shaftencompassed by an expandable membranous structure in an unexpandedstate.

FIG. 4B is a view of the distal end of the surgical probe shaft with thespring-like structure coaxial to the surgical probe shaft encompassed byan expandable membranous structure in an expanded state.

FIG. 5A is a side view of the distal end of a surgical probe shaft withthe spring-like structure comprising a lateral curve in a tangentialrelationship with the surgical probe shaft encompassed by an expandablemembranous structure in an unexpanded state.

FIG. 5B is a view of the distal end of the surgical probe shaft with thespring-like structure comprising a lateral curve in a tangentialrelationship with the surgical probe shaft encompassed by an expandablemembranous structure in an expanded state.

FIG. 5C is a side view that is 90 degrees from the first side view ofFIG. 5A.

FIG. 5D is a view that is 90 degrees from the first side view of FIG.5B.

FIG. 6A is a view of the distal end of a surgical probe shaft with thespring-like structure comprising a loop encompassed by an expandablemembranous structure in an unexpanded state.

FIG. 6B is a view of the distal end of the surgical probe shaft with thespring-like structure comprising a loop encompassed by an expandablemembranous structure in an expanded state.

FIG. 6C is a view that is 90 degrees from the first side view of FIG.6A.

FIG. 6D is a view that is 90 degrees from the first side view of FIG.6B.

FIG. 6E is a view of the distal end of a surgical probe shaft with thestructure comprising a continuous member encompassed by anon-distensible structure.

FIG. 6F is a view that is 90 degrees from the first side view of FIG.6E.

FIG. 6G is a view of the embodiment of FIG. 6E when pressedlongitudinally against a tissue region for treatment.

FIG. 6H is a view of the embodiment of FIG. 6E when pressed laterallyagainst a tissue region for treatment.

FIG. 7 is a cross sectional schematic view of the distal end of asurgical probe where the spring-like structure is configured as a closedcryogenic liquid evaporator.

FIG. 8 is a cross sectional schematic view of the distal end of asurgical probe where the spring-like structure is encompassed by anexpandable membranous structure with the membranous structure configuredas a liquid cryogen evaporation chamber.

FIG. 9 is an internal lateral view of the nasal canal showing a surgicalprobe with the spring-like structure pressed against a lateral nasalwall in position for a cryo-ablation of a posterior nasal nervefunction.

FIG. 10A is a front view illustration the distal end of a paddle balloonablation probe with its expandable structure in its un-expanded state.

FIG. 10B is a side view illustration of FIG. 10A.

FIG. 10C is a front view illustration of the distal end of a paddleballoon ablation probe with its expandable structure in its expandedstate.

FIG. 10D is a side view illustration of FIG. 10C.

FIG. 11A is a front view illustration of the distal end of a paddleporous balloon ablation probe.

FIG. 11B is a side view illustration of FIG. 11A.

FIG. 12A is a front view illustration the distal end of a paddle doubleballoon ablation probe with its expandable structure in its un-expandedstate.

FIG. 12B is a side view illustration of FIG. 12A.

FIG. 12C is a front view illustration of the distal end of a paddledouble balloon ablation probe with its expandable structure in itsexpanded state.

FIG. 12D is a side view illustration of FIG. 12C.

FIG. 13A through 13D are schematic sectional coronal illustrations of anasal cavity depicting the surgical access to a middle meatus andcryogenic ablation of a sphenopalatine brand and foramen.

FIG. 14A is an internal lateral view of the nasal cavity showing ananatomical target for ablation of parasympathetic nervous function ofthe middle turbinate.

FIG. 14B is an internal lateral view of the nasal cavity showing ananatomical target for ablation of posterior nasal nerves.

FIG. 14C is an internal lateral view of the nasal cavity showing ananatomical target for ablation of posterior nasal nerves using anintermittent line of ablation.

FIG. 14D is an internal lateral view of the nasal cavity showing ananatomical target for ablation of posterior nasal nerves.

FIG. 15A is a schematic illustration of a cryosurgical probe configuredfor cryo-ablation of posterior nasal nerves comprising a spatula shapedcryosurgical tip.

FIG. 15B defines a section view of the cryosurgical probe's cryosurgicaltip.

FIG. 15C is a cross sectional view of the cryosurgical probe's tip.

FIG. 16A is a schematic illustration of the distal end of an alternativeembodiment of the cryosurgical probe comprising a bullet shapedcryo-ablation element at the distal end of an angled shaft.

FIG. 16B is a schematic illustration of the distal end of an alternativeembodiment of the cryosurgical probe comprising a bullet shapedcryo-ablation element at the distal end of a user deflectable probeshaft.

FIGS. 16C and 16D are schematic illustrations of the distal end of analternative embodiment of the cryosurgical probe where the cryo-ablationelement is configured for producing multiple discrete cryo-ablationssimultaneously.

FIG. 17A is a schematic illustration of the distal end of an alternativeembodiment of the cryosurgical probe comprising a semi-circularcryo-ablation element.

FIG. 17B is a schematic illustration of the ablation morphologyresulting from use of the semi-circular cryo-ablation element.

FIG. 17C is a schematic illustration of the distal end of an alternativeembodiment of the cryosurgical probe comprising a spiraled cryo-ablationelement.

FIG. 18A is a schematic illustration of cryo-ablation balloon probeconfigured for cryo-ablation of posterior nasal nerves.

FIG. 18B is a schematic illustration of the distal end of thecryo-ablation balloon probe detailing the geometry of the cryo-ablationballoon.

FIG. 18C is a schematic illustration of an alternate embodiment of thecryo-ablation balloon probe comprising an insulating chamber within thecryo balloon structure.

FIG. 18D is a schematic illustration of the distal end of an alternativeembodiment of the cryo-ablation balloon probe comprising a tee shapedcryo-ablation balloon.

FIG. 18E is a schematic illustration of the distal end of an alternativeembodiment of the cryo-ablation balloon probe comprising a “J” shapedcryo-ablation balloon.

FIG. 19A is a schematic illustration of the distal end of an alternateembodiment a cryo-ablation probe comprising a cryo-ablation element withsuction stabilization.

FIG. 19B is a cross sectional view of the distal end of the alternativeembodiment showing the configuration of the cryo-ablation element andthe suction stabilization means.

FIG. 20A is a schematic illustration of a radiofrequency (RF) ablationprobe configured for ablation of the posterior nasal nerves with abi-polar ring electrode ablation element on an “J” shaped distal probeshaft.

FIG. 20B is a schematic illustration of the distal end of an alternativeembodiment of an RF ablation probe comprising a bi-polar ring electrodeablation element on an “J” shaped distal probe shaft.

FIG. 20C is a schematic illustration of an alternative embodiment of thedistal end of an RF ablation probe comprising a bi-polar electrodeablation element on an “J” shaped distal probe shaft with the electrodesdisposed in a lateral array.

FIG. 20D is a schematic illustration of an alternative embodiment of thedistal end of an RF ablation probe comprising a bi-polar electrodeablation element on a “U” shaped distal probe shaft with the electrodesdisposed in a lateral array.

FIG. 20E is a schematic illustration of the distal end of an alternativeembodiment of an RF ablation probe comprising a bi-polar electrodeablation element on a user deployable “T” shaped structure.

FIG. 21A is a schematic illustration of an RF ablation probe configuredfor ablation of posterior nasal nerves comprising an array of RFablation electrodes disposed on a planar surface and a fluid irrigationmeans associated with the electrodes.

FIG. 21B is a schematic illustration of the distal end of the RFablation probe showing the arrangement of the ablation electrodes andthe associated fluid irrigation means.

FIG. 22A is a schematic illustration of an alternative RF ablation probecomprising an electrode array disposed on a planar surface; a fluidirrigation means associated electrodes, and a deployable needleconfigured for injecting a liquid into a sub-mucosal space.

FIG. 22B is a schematic illustration of the distal end of thealternative embodiment RF ablation probe showing the arrangement of theablation electrodes and the associated fluid irrigation means.

FIG. 22C is a schematic illustration of the distal end of thealternative embodiment RF ablation probe showing the arrangement of theablation electrodes and the associated fluid irrigation means with theneedle deployed.

FIG. 23A is a schematic illustration of an RF interstitial needleablation probe configured for interstitial ablation of theparasympathetic nervous function of a nasal turbinate(s).

FIG. 23B is a schematic illustration of the distal end of the RFinterstitial needle ablation probe.

FIG. 24A is a cross sectional view of the distal end of an RFinterstitial needle ablation comprising a deployable and retractablearray of RF ablation needles configured for lateral deployment showingthe needle array retracted.

FIG. 24B is a cross sectional view of the distal end of an RFinterstitial needle ablation comprising a deployable and retractablearray of RF ablation needles configured for lateral deployment showingthe needle array deployed.

FIG. 24C is a cross sectional view of the distal end of an RFinterstitial needle ablation comprising a deployable and retractablearray of RF ablation needles configured for axial deployment showing theneedle array retracted.

FIG. 24D is a cross sectional view of the distal end of an RFinterstitial needle ablation comprising a deployable and retractablearray of RF ablation needles configured for axial deployment showing theneedle array deployed.

FIG. 25A is a schematic illustration of an integrated flexible circuitconfigured for use with an RF ablation probe comprising an RF energysource and control circuits at one end, and an RF ablation electrodearray at the opposite end.

FIG. 25B is a schematic illustration of the RF ablation electrode arrayof the flexible circuit mounted on the distal shaft of an RF ablationprobe that is configured for ablation of posterior nasal nerves.

FIG. 26A is an in situ schematic illustration of the RF ablation probedepicted in FIGS. 22A through 22C showing the needle injecting ananesthetic into the sub-mucosal space prior to an RF ablation ofposterior nasal nerves.

FIG. 26B is an in situ schematic illustration of the resulting ablation.

FIG. 27 is an in situ schematic illustration of an ablation of posteriornasal nerves using the RF interstitial needle ablation probe depicted inFIGS. 23A and 23B.

FIG. 28 is an in situ illustration of the ablation of the posteriornasal nerves at the ablation target depicted in FIG. 14D.

FIG. 29 is an in situ illustration of the ablation of the posteriornasal nerves at the ablation target depicted in FIG. 24A.

FIG. 30 is an in situ illustration of the ablation of the posteriornasal nerves at the ablation target area depicted in FIG. 14B.

FIG. 31A is a schematic illustration of the ablation probe and aninsulated probe guide configured to protect the nasal septum fromthermal injury during an ablation of the posterior nasal nerves.

FIG. 31B is an in situ illustration of an ablation probe configured forablation of the posterior nasal nerves which comprises an insulatingstructure configured to protect the nasal septum.

FIG. 31C is an in situ illustration of an ablation probe configured forablation of the parasympathetic nervous function of posterior nasalnerves which comprises a space creating structure configured to protectthe nasal septum.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is an internal view of the nasal cavity showing the relevantnasal anatomy. Shown for orientation is the lateral nasal cavity wall 4,the nose 1, nostril 2, and the upper lip 3. The superior turbinate 5,middle turbinate 6, and inferior turbinate 7 are depicted along with theassociated nerves relevant to this invention shown in dashed lines. Theposterior nasal nerves 10,11 and 12 are responsible for theparasympathetic control of the nasal mucosa including turbinates. Theseposterior nasal nerves (PNNs) originate from the sphenopalatineganglion. At times other accessory posterior nasal nerves (APNNs) mayoriginate from the greater palatine nerve or from the bony plateunderneath the mucosa.

FIG. 2 is a schematic illustration of surgical probe 29, which isconfigured for cryo-ablation of posterior nasal nerve function for thetreatment of rhinitis. Surgical probe 29 comprises: probe shaft 20, withshaft distal end 21 and shaft proximal end 27; surgical hand piece 23,e.g., with pistol grip 24, finger grip 25, pistol trigger flow controlvalve actuator 26, button flow control flow valve actuator 22, fingergrip barrel 28, cryogen reservoir housing 29; and distal end effector 30(e.g., spring-like structure) with end effector proximal end 31, and endeffector distal end 32. Surgical probe shaft 20 is between, e.g.,approximately 1 mm and 4 mm in diameter, and between, e.g.,approximately 4 cm and 10 cm in length. Surgical probe shaft 20 may befabricated from various biocompatible materials such as a surgical gradestainless steel hypodermic tube, or may alternatively be fabricated froma polymeric extrusion. Surgical probe shaft 20 comprises at least oneliquid cryogen delivery channel between shaft distal end 21 and shaftproximal end 27. Probe shaft 20 is substantially rigid in one variation,and may also be configured to be malleable and shape formable by theuser. The distal end effector 30 is shown having multiple variationsdescribed herein and may be optionally interchanged depending upon whichparticular embodiment is utilized by a practitioner.

Although probe shaft 20 is depicted to be straight, it is well withinthe scope of this invention probe shaft 20 may be manufactured with atleast one curved segment. Surgical hand piece 23 is disposed on theproximal end 22 of probe shaft 20. Surgical hand piece 23 comprises aliquid cryogen reservoir, not shown, that may be conventionally suppliedwith liquid cryogen and configured for a single patient use.Alternatively, surgical hand piece 23 may be configured for use with auser replaceable liquid cryogen reservoir in the form of a cartridge.Liquid cryogen cartridges are readily commercially available from manysources. In yet another alternative, a reservoir separate from thedevice may be fluidly coupled to the hand piece 23. Surgical hand piece23 may further comprise a liquid cryogen flow control valve, not shown,that may be disposed in fluidic communication with the liquid cryogenreservoir and the liquid cryogen channel in probe shaft 20.

Surgical device 29 may be configured to be held like a pistol by thesurgeon or practitioner using pistol grip 24, or the surgeon orpractitioner may hold surgical device 29 like a writing utensil usingfinger grips 25, with finger grip barrel 28 residing between the thumband index finger of the surgeon. Surgical device 29 may be configuredwith, e.g., two or more liquid cryogen flow control valve actuatorscomprising pistol trigger liquid cryogen flow control actuator 26, whichmay be used to control the flow of liquid cryogen when the surgeon holdssurgical device 29 using pistol grip 24. Liquid cryogen flow controlactuator button 22 may be used to control the flow of liquid cryogenwhen the surgeon holds surgical device 29 by finger grips 25. Probeshaft 20 may be configured to be rotatably coupled to the surgicaldevice 29 to facilitate positioning of distal end effector 30 (e.g.,spring-like structure) without having to rotate the surgical device 29excessively. Distal end effector 30 (e.g., spring-like structure), withend effector proximal end 31, and end effector distal end 32 is disposedon the distal end 21 of probe shaft 20 as shown. Distal end effector 30(e.g., spring-like structure) is configured as a liquid cryogenevaporator, and is configured to be pressed against the lateral nasalwall within the cul-de-sac described above for cryo-ablation of at leastone posterior nasal nerve. The construction and the function of distalend effector 30 (e.g., spring-like structure), and alternativeembodiments are described in detail below.

Surgical device 29 may be configured as a simple mechanical device thatis void of electronics as shown. Alternatively, surgical device 29 maybe configured with at least one electronic function. In one embodiment,a temperature sensor may be disposed in the vicinity of distal endeffector 30 (e.g., spring-like structure) and used to measure, display,or control a temperature of surgical interest. A temperature sensor maybe configured to sense the temperature of evaporating cryogen withindistal end effector 30 (e.g., spring-like structure). A temperaturesensor may also be configured to sense the temperature of a tissue ofsurgical interest. The liquid cryogen control valve 22 may alsooptionally comprise a servo mechanism configured to respond to a sensedtemperature to modulate the flow of cryogen in order to control adesired surgical parameter.

In addition to a temperature sensing capability, surgical device 29 maybe configured with a camera and/or a light source disposed in thevicinity of distal end 21 of probe shaft 20. The camera and light sourcemay be used, e.g., to identify nasal anatomical landmarks, and may beused to guide the placement of distal end effector 30 (e.g., spring-likestructure) against the lateral nasal wall for a cryo-ablation of thefunction of a target posterior nasal nerve. An ultrasonic or opticaldoppler flow sensor may also be disposed in the vicinity of distal end21 of probe shaft 20 and be used, e.g., to locate the major arteryassociated with the target posterior nasal nerve, as a means forlocating the target posterior nasal nerve. In addition, one or moreelectrodes may be disposed in the vicinity of distal end 21 of probeshaft 20, which may be used for electrical stimulation or electricalblockade of the function of a target posterior nasal nerve using theobserved physiological response to the stimulation or blockade toconfirm correct surgical positioning of distal end effector 30 (e.g.,spring-like structure) prior to a cryo-ablation, and/or to confirmeffectiveness of a cryo-ablation by the determination of a change in thephysiological response from before and after a cryo-ablation.

Any number of temperature sensing, endoscopic instruments, servocontrolled cryogen control valves, ultrasonic or optical doppler flowdetection, and/or electrical nervous stimulation and blockade mechanismsmay be optionally incorporated into the devices described herein. Also,providing a surgical probe as described here with a liquid cryogenreservoir that is external to the probe hand piece is also within thescope of this invention.

FIG. 3A is a schematic illustration of an alternative end effectorembodiment, which comprises spring-like structure 39 which is configuredin a coaxial arrangement with probe shaft 20. FIG. 3B is a schematicillustration of the distal end of an alternative embodiment surgicalprobe 43 which comprises spring-like structure 44, which is configuredto with a lateral curve as shown with proximal end 46 in a tangentialrelationship with the distal end 21 of probe shaft 20. FIG. 3C is aschematic illustration of the distal end of an alternative embodimentsurgical probe 48, with spring-like structure 49 configured as a loopstructure as shown, with both ends of spring-like structure 49 in asubstantially tangential relationship with distal end 21 of probe shaft20. The three alternate spring-like structure embodiments 39, 44, and 49depicted in FIGS. 3A, 3B, and 3C are configured as liquid cryogenevaporators, where the outer surface of each spring-like structure mayachieve a temperature between, e.g., approximately −20 Deg. C. to −90Deg. C., in response to liquid cryogen evaporation within. As previouslydescribed, the end effector described here may be optionally replaced byany of the other end effector embodiments described herein.

Spring-like structures 39, 44, and 49 are substantially flexible and areconfigured to conform to the morphology of a lateral nasal wallproximate to a target posterior nasal nerve with a substantially uniformcontact pressure. Spring-like structures 39, 44, and 49 may beconfigured to be partially malleable and form shapeable by the user,while retaining a spring-like resilience during use. Spring-likestructures 39 and 44 comprise distal end 40 and respectively, andproximal end 41 and 46 respectively. Spring-like structures 39 and 44comprise end cap 38, which functions as a pressure bulkhead defining thedistal end of the liquid cryogen evaporator that resides within, whichis described in detail below. Spring-like structures 39, 44, and 49comprise a tightly coiled wire that forms a central chamber, and anouter surface. A thin polymeric liner is disposed on the inner surfaceof the central chamber and functions to contain the evaporating cryogenwithin the central chamber. Cryogen is introduced into the centralchamber through a liquid cryogen supply line, which runs through probeshaft 20, and is in fluidic communication with the liquid cryogen flowcontrol valve and the liquid cryogen reservoir previously described.Evaporated cryogen gas may be vented into the room out of the centralchamber, through probe shaft 20, then out of a vent port disposed in thevicinity of proximal end 22 of probe shaft 20, not shown, or disposed inthe surgical hand piece, also not shown. The construction and functionof the disclosed embodiments of the spring-like structures is describedin detail below.

FIG. 4A is a schematic illustration of a side view of the distal end ofalternative embodiment surgical probe 55 comprising expandablemembranous structure 58 encompassing spring-like structure 57 in anun-expanded state. FIG. 4B is a schematic illustration of a side view ofthe distal end of surgical probe 55 with expandable structure orexpandable membranous structure in an expanded state. In the depictedembodiment, expandable membranous structure 58 is configured as a liquidcryogen evaporation chamber. Liquid cryogen is introduced into theinterior of expandable membranous structure 58 from spring-likestructure 57. Surgical probe 55 is configured so expandable membranousstructure expands to a predetermined size and shape in response toliquid cryogen evaporation within. While structure 58 may be expandableto a predetermined size and shape, the structure may be comprised of anon-distensible material while in other variations, structure 58 mayalternatively be comprised of a distensible material which allows forthe expanded size and shape to vary depending upon the volume of cryogenintroduced. Surgical probe 55 is configured such that the outer surfaceof expandable membranous structure 58 will be between approximately −20Deg. C. to −90 Deg. C. during cryogen evaporation within. The expandedsize or shape of expendable membranous structure 58 is configured tosubstantially contact the surface of the cul-de-sac (element 13 in FIG.1 which indicates the region of tissue region defined and surrounded bythe middle nasal turbinate, inferior nasal turbinate, and lateral wall)when pressed against the lateral nasal wall be the surgeon. Expandablemembranous structure may be configured to form a hollow bulbousstructure in its expanded state, and comprises a single ostium 59configured for adhesive bonding to distal end 62 of probe shaft 56 usingadhesive bond 60. Cryogen exhaust vent 61 comprises at least onefenestration in distal end 62 of probe shaft 40, which is in fluidiccommunication with a proximal vent port, not shown, and the room. Apressure relief valve, not shown, may be disposed in the fluid pathbetween the interior of expandable membranous structure 58 and the roomto control the pressure within expandable membranous structure 58, andthe degree of expansion during liquid cryogen evaporation. Theconstruction and functionality of surgical probe embodiments comprisingan expandable membranous structure are described in detail below.

FIG. 5A is a schematic illustration of a side view of the distal end ofalternate embodiment of surgical probe 68 comprising expandablemembranous structure 69 encompassing spring-like structure 70.Spring-like structure 70 is configured with a lateral bend as depicted.Expandable membranous structure 69 is depicted in its un-expanded state.FIG. 5B is a schematic illustration of the same side view in FIG. 5A ofalternate embodiment surgical probe 68 with expandable membranousstructure 69 in its expandable state. FIG. 5C is a schematic side viewillustration taken at view A-A from FIG. 5A. FIG. 5D is a schematic sideview illustration taken at view B-B from FIG. 5B. Surgical probe 68 isconfigured with expandable membranous structure 69 functioning as aliquid cryogen evaporation chamber as depicted in FIGS. 4A and 4B.Liquid cryogen enters the interior of expandable membranous structure 69from encompassed spring-like structure 70. Evaporated cryogen gas exitsthe interior of expandable membranous structure 69 throughfenestration(s) 144 in distal end 143 of probe shaft 141 and exitssurgical probe 68 proximally into the room. Spring-like structure 70 isconfigured to pre-tension membranous structure 69 in one radial axis toa greater extent than a second radial axis in a manner that causesexpansion to be constrained in the radial axis with greatestpre-tensioning. In FIGS. 5A and 5B, spring-like structure 70 isconfigured to pre-tension expandable membranous structure 69 to agreater extent in the radial axis that is normal to the view axis. InFIGS. 5C and 5D, spring-like structure 70 is configured to pre-tensionexpandable membranous structure 69 to a greater extent in the radialaxis that is parallel to the view axis. FIG. 5A and FIG. 5C depictsurgical probe 68 with expandable membranous structure 69 in itsun-expanded state. FIGS. 5B and 5D depict surgical probe 68 withexpandable membranous structure 69 in its expanded state. Pre-tensioningof expandable membranous structure 69 provides a means for achieving apredetermined expanded shape for optimal matching of the morphology ofthe target area of the lateral nasal wall.

FIG. 6A is a schematic illustration of a side view of the distal end ofalternate embodiment of surgical probe 79 comprising expandablemembranous structure 80 encompassing spring-like structure 82.Spring-like structure 82 is configured as a loop structure as depicted.Expandable membranous structure 80 is depicted in its un-expanded state.FIG. 6B is a schematic illustration of the same side view in FIG. 6A ofalternate embodiment surgical probe 79 with its expandable membranousstructure 80 in its expandable state. FIG. 6C is a schematic side viewillustration taken at view C-C from FIG. 6A. FIG. 6D is a schematic sideview illustration taken at view D-D from FIG. 6B. Surgical probe 79 isconfigured with expandable membranous structure 80 functioning as aliquid cryogen evaporation chamber as depicted in FIGS. 4A and 4B.Liquid cryogen enters the interior of expandable membranous structure 80from encompassed spring-like structure 82. Evaporated cryogen gas exitsthe interior of expandable membranous structure 69 throughfenestration(s) in distal end 146 of probe shaft 145 and exits surgicalprobe 79 proximally into the room. Spring-like structure 82 isconfigured to pre-tension expandable membranous structure 80 in oneradial axis to a greater extent than a second radial axis in a mannerthat causes expansion to be constrained in the radial axis with greatestpre-tensioning. In FIGS. 6A and 6B, spring-like structure 82 isconfigured to pre-tension membranous structure 80 to a greater extent inthe radial axis that is normal to the view axis. In FIGS. 6C and 6D,spring-like structure 82 is configured to pre-tension expandablemembranous structure 80 to a greater extent in the radial axis that isparallel to the view axis. FIG. 6A and FIG. 6C depict surgical probe 79with expandable membranous structure 80 in its un-expanded state. FIGS.6B and 6D depict surgical probe 79 with expandable membranous structure80 in its expanded state. Pre-tensioning of expandable membranousstructure 80 provides a means for achieving a predetermined expandedshape for optimal matching of the morphology of the target area of thelateral nasal wall.

Another alternative embodiment is illustrated in the side view of FIG.6E which shows a structure or member 83 which is formed into a loopedand elongated structure having arcuate edges for presenting anatraumatic surface. Rather than being formed as a spring like structure,the structure 83 may be formed of a relatively rigid wire or memberinstead which maintains its configuration when pressed against a tissuesurface. Structure 83 may form a continuous structure which defines anopening there through such as a looped or elongated and looped memberwhich is open through the loop. The structure 83 may be containedentirely within the expandable structure 81 which may be formed to havea predefined shape which is distensible or non-distensible when inflatedby the cryogen. Moreover, the expandable structure 81 may be formed tosurround the structure 83 entirely without being supported by orattached to the structure 83 itself. Such a structure 83 may provide aconfiguration which presents a low-profile as the device is advancedinto and through the nasal cavity and between the nasal turbinatetissues. Yet because of the relatively flattened shape and rigidity andintegrity of the structure 83, the structure 83 may be used tomanipulate, move, or otherwise part the tissues of the nasal cavitywithout having to rely upon the expandable structure 81. Additionally,the low-profile enables the structure 83 to be positioned desirablywithin the narrowed confines of, e.g., the cul-de-sac in proximity tothe posterior nasal nerves (as shown by cul-de-sac 13 shown in FIG. 1).When the expandable to structure 81 is in its deflated state, it mayform a flattened shape and when inflated, the expandable structure 81may inflate into a configuration which remains unsupported by orattached to the structure 83. Because the structure 83 may be formed ofa member which solid along its length, the cryogen may be introduceddirectly into the expandable structure 8I through a distal openingdefined in the probe shaft 145.

Alternatively, structure 83 may be formed of a hollow tubular memberwhich itself is formed into the continuous or looped shape. In such anembodiment, the cryogen may be optionally introduced through the hollowtubular member and dispersed within the interior of the expandablestructure 81 through one or more openings which may be defined along thetubular member. In yet another alternative, the structure 83 may beformed into a flattened shape rather than a looped shape. In thisconfiguration, the structure may be either solid or hollow such thatthat cryogen may be introduced through the structure and into theinterior of the expandable structure 81 via one or more openings definedalong the structure.

The structure 83 may extend and remain attached to the probe shaft 145,but the remainder of the structure 83 which extends within theexpandable structure 81 may remain unattached or unconnected to anyportion of the expandable structure 81. Hence, once the expandablestructure 81 is inflated by the cryogen, the structure 83 may beadjusted in position or moved via manipulating the probe shaft 145relative to the interior of the expandable structure 81 to enable thetargeted positioning and cooling of the tissue region when in contactagainst the outer surface of the expandable structure 81. For instance,the structure 83 may press laterally upon a particular region of theunderlying tissue to stretch or thin out the contacted tissue region tofacilitate the cryogenic treatment. When the structure 83 is adjusted inposition relative to the expandable structure 81, the expandablestructure 81 may remain in a static position against a contacted tissueregion allowing for limited repositioning of the structure 83 within.

Alternatively in other variations, the structure 83 may be attachedalong the interior of the expandable structure 81 partially atparticular portions of the structure 83 or along the entirety of thestructure 83. For instance, structure 83 may be attached, adhered, orotherwise coupled over its entirety to expandable structure 81 while inother variations, a distal portion of structure 83 may be attached,adhered, or otherwise coupled to a distal portion of the expandablestructure 81 while in yet other variations, portions of the structure 83may be attached, adhered, or otherwise coupled to the expandablestructure 81 along its side portions. Any of these variations may beoptionally utilized depending upon the desired interaction and treatmentbetween the structure 83, expandable structure 81, and underlying tissueregion to be treated.

In yet another alternative variation, the lumen 84 for introducing thecryogen into the interior of the expandable structure 81 may be extendedpast the distal end of the probe shaft such that the cryogen is releasedwithin the interior at a more distal location. As shown, the cryogenlumen 84 may be supported along the structure 83, e.g., via a bar ormember 85 which extends across the structure 83. This particularvariation may allow for the cryogen to be introduced into the distalportion of the interior of the expandable member 81. Either thisvariation or the variation where the cryogen is released from an openingof the probe shaft may be utilized as desired.

FIG. 6F shows a side view of the embodiment of FIG. 6E illustrating howthe structure 83 can be formed from a relatively flattened configurationrelative to the inflated expandable structure 81. Because of thestructural integrity of structure 83 and its relatively flattenedprofile, the structure 83 may provide for targeted treatment of thetissue when contacted by the device. FIG. 6G shows the side view of theinflated expandable structure 81 when pressed in a longitudinaldirection by its distal tip against the underlying tissue surface S. Therelative strength of the structure 83 provides for the ability to pressthe device against the tissue surface such that the remainder of theexpandable structure 81 may maintain its inflated configuration topotentially insulate the other surrounding tissue regions. FIG. 6Hlikewise shows the device when the structure 83 is pressed laterallyalong its side against the tissue surface S such that the structure 83lies flat. The contacted tissue region may be treated while theremainder of the surrounding tissue is potentially insulated by theexpanded structure 81.

While the treatment end effector is designed for application along thetissue region defined by the cul-de-sac, the same end effector may beused in other regions of the nasal cavity as well. For instance, oncethe ablation is performed along the cul-de-sac, the end effector maythen be moved to an adjacent tissue region, e.g., region immediatelyinferior to the cul-de-sac, and ablation treatment may be effectedagain. Additionally and/or alternatively, the end effector may also beused to further treat additional tissue regions, e.g., posterior aspectof the superior, middle, and/or inferior turbinates (any one, two, orall three regions). In either case, once the cul-de-sac has beenablated, the end effector may remain in place until the tissue regionhas thawed partially or completely before the end effector is moved tothe adjacent tissue region for further treatment.

Once the treatment is completed, or during treatment itself, the tissueregion may be assessed utilizing any number of mechanisms. For instance,the tissue region may be visually assessed utilizing an imager duringand/or after ablation.

As described herein, the device may be utilized with a temperaturesensor, e.g., thermistor, thermocouple, etc., which may be mounted alongthe shaft, within or along the expandable structure 81, along thestructure 83, etc., to monitor the temperature not only of the cryogenbut also a temperature of the tissue region as well under treatment.

Additionally and/or alternatively, the expandable structure 81 may alsobe vibrated while maintaining the structure 83 against the interior ofthe expandable structure 81 and the tissue region utilizing any numberof vibrational actuators which may be mounted anywhere along the deviceas appropriate. The vibrations may be applied directly against thetissue region or, e.g., through a layer of gel to facilitate thevibrational contact with the tissue.

Additionally and/or alternatively, other biocompatible agents may beused in combination with the cryogenic treatment. For instance, in onevariation, an anesthetic may be applied to the tissue region to betreated prior to or during the cryogenic treatment. This and otheralternative features described may be utilized not only with thevariation shown and described in FIGS. 6E and 6F but with any otherembodiments described herein.

FIG. 7 is a cross sectional schematic illustration of the distal end ofa generic surgical probe 89, which represents the construction andfunctionality of previously described surgical probe end effectorsdescribed above. Depicted is the distal end of probe shaft 90, liquidcryogen supply line 91, wire coil 92, inner liner 93, end cap 94,metering orifices 95, liquid cryogen 96, liquid cryogen evaporationchamber 97, and cryogen exhaust path 98. Liquid cryogen evaporationchamber is defined by central channel 134 and inner liner 93 of wirecoil 92, end cap 94 at its distal end, probe shaft 90 at its proximalend. Wire coil 92 may be welded to end cap 94 and probe shaft 90 asshown. Alternatively, adhesive may be used for assembly. Probe shaft 90may be formed from a surgical grade stainless steel hypodermic tube withan outside diameter between, e.g., approximately 1 mm and 4 mm. Wirecoil 92 comprises a tightly coiled flat wire with a coil pitch thatapproximates the axial thickness 136 of wire 135 as shown. Wire 135 maybe a stainless steel wire, or may alternatively be a nickel titaniumsuper elastic alloy wire. Wire 135 has an axial thickness 136 between,e.g., approximately 0.5 mm and 1.5 mm, and a radial thickness 137between, e.g., approximately 0.1 mm and 0.5 mm. Wire 135 mayalternatively be a round wire with a diameter between, e.g.,approximately 0.25 mm and 1.0 mm.

Inner liner 93 is depicted being disposed on the inner wall of wire coil92. Inner liner 93 is configured to provide a fluid tight seal of wirecoil 92. Inner liner 93 may be a polymeric material such aspolyethylene, or PTFE. Alternatively a polymeric line may be disposed onthe outer surface 133 to provide a fluid tight seal of wire coil 92.Cryogen supply line 91 in fluidic communication with the supply ofliquid cryogen in the liquid cryogen reservoir and liquid cryogen flowcontrol valve in the surgical hand piece, not shown. Cryogen supply line91 may be made from a thin walled tube with a high pressure rating suchas a polyimide tube. Cryogen supply line 91 delivers liquid cryogen 96into liquid cryogen evaporation chamber 97 through metering orifice(s)95. Liquid cryogen supply line 91 has an inner diameter between, e.g.,approximately 0.2 mm and 0.8 mm, and a wall thickness between, e.g.,approximately 0.05 mm and 0.5 mm.

Metering orifices 95 are configured to comprise a distribution offenestrations in the distal end of liquid cryogen supply line 91 asshown, and are configured to distribute liquid cryogen 96 into liquidcryogen evaporation chamber 97 in a substantially uniform manner. Thediameter and number of metering orifices 95 are configured such that theflow of liquid cryogen 96 into liquid cryogen evaporation chamber 97 issufficient to lower the temperature of outer surface 133 to between,e.g., approximately −20 Deg. C., and −50 Deg. C. during liquid cryogenevaporation in order to effect a cryo-ablation, while limiting the flowof liquid cryogen 96 into liquid cryogen evaporation chamber 97 so thatsubstantially all liquid cryogen evaporates within liquid cryogenevaporation chamber 97. As depicted, liquid cryogen evaporation chamber97 is an empty space. Alternatively, liquid cryogen evaporation chamber97 may comprise a porous material configured to absorb the liquidcryogen 96 and prevent the liquid cryogen from leaving liquid cryogenevaporation chamber 97 while in a liquid state. Cryogenic gas leavesliquid cryogen evaporation chamber 97 through central channel 139, andis vented into the room.

FIG. 8 is a cross sectional schematic illustration of the distal end ofgeneric surgical probe 104 representing the construction andfunctionality of surgical probe embodiments 55, 68, and 79 previouslydescribed and depicted in FIGS. 4A and 4B, FIGS. 5A through 5D, andFIGS. 6A through 6D, respectively. Depicted is the distal end of probeshaft 105, wire coil structure 106, end cap 107, liquid cryogen supplyline 108, expandable membranous structure 109, in its expanded state,ostium 110, adhesive bond 111 between ostium 110 and probe shaft 105,cryogen gas exhaust vent 112, exhaust gas flow path 113, pressurebulkhead 114, liquid cryogen evaporation chamber 115, and liquid cryogen116. Wire coil 106, probe shaft 105, end cap 107, and cryogen supplyline 108 are substantially similar to corresponding elements describedin detail and depicted in FIG. 7, therefore, no further description iswarranted. Expandable membranous structure 109, ostium 110, adhesivebond 111, cryogen gas exhaust vent 112, and exhaust gas flow path 113are substantially similar to corresponding elements described in detailand depicted in FIGS. 4A, 4B, 5A through 5D, and 6A through 6D,therefore no further description is warranted. Liquid cryogen chamber139 is defined by spring coil 106, end cap 107, and pressure bulkhead114. Liquid cryogen 116 enters liquid cryogen chamber 139 through liquidcryogen supply line 108, and through liquid cryogen ports 137. Wire coil106 is configured to meter liquid cryogen 116 from liquid cryogenchamber 139 into liquid cryogen evaporation chamber 115 in a manner thatsprays liquid cryogen 116 in the direction of interior surface 141 ofexpandable membranous structure 109 so that the liquid cryogen rapidlyevaporates upon contact with inner surface 141. A perforated polymericliner, not shown, disposed upon wire coil 106 may be used to provideproper metering and spatial distribution of liquid cryogen 116.

FIG. 9 is an internal view of the nasal cavity showing surgical probe148 comprising an expandable membranous structure 123, configured as aliquid cryogen evaporator in position for a cryo-ablation of at leastone posterior nasal nerve associated with middle nasal turbinate 129, orinferior nasal turbinate 128. Probe shaft 122 is associated with asurgical hand piece, not shown. Endoscope 126, proximal end not shown,with field of view 127 is positioned to guide the correct surgicalplacement of spring-like structure 125, and expandable membranousstructure 123 against lateral nasal wall 130 at region 124 posterior tothe middle turbinate as shown. Expandable membranous structure 123 isdepicted in an expanded state. Alternatively, an endoscopic imagingmeans may be incorporated into the to surgical probe 148, along itsshaft, which may comprise a CCD or CMOS imager

FIGS. 10A thru 10D are schematic illustrations of the distal end 151 ofalternative embodiment paddle balloon probe 150. Depicted is probe shaft154, expandable structure 153, and paddle structure 152. FIG. 1 OA is afront view illustration of distal end 151 with expandable structure 153in an un-expanded state. Expandable structure 153 is maintained in itsun-expanded state during introduction to, and removal from the targetregion of the nasal anatomy. Suction may be applied by a suction meansto maintain expandable structure 153 in its un-expanded state. FIG. 10Bis a side view illustration of the distal end 151 of paddle balloonprobe 150 with expandable structure 153 in its un-expanded state. FIG.10C is a front view illustration of the distal end 151 of paddle balloonprobe 150 with expandable structure 153 in its expanded or inflatedstate. FIG. 10D is a side view illustration of the distal end of paddleballoon probe 150 with expandable structure 153 in its expanded orinflated state. Paddle 152 is configured for access to middle meatus ofthe lateral nasal wall by means of insertion between the middle nasalturbinate and the inferior nasal turbinate, as illustrated in FIGS. 13Athru 13D below. Paddle structure 152 is a rounded rectangular shape asshown with a major dimension between approximately, e.g. 8 mm and 16 mm,and a minor dimension between approximately, e.g. 4 mm and 10 mm. Thethickness of paddle structure 152 is between approximately, e.g. 1 mmand 3 mm. Paddle structure 152 is sufficiently rigid to access themiddle meatus between the middle nasal turbinate and the inferior nasalturbinate, and is sufficiently flexible to avoid trauma to the nasalanatomy during use. Expandable structure 153 comprises a membrane thatis bonded to paddle structure 152 in a manner that forms a air tightbladder as shown. Paddle balloon probe 150 is configured forintroduction of a liquid cryogen into the bladder formed by paddlestructure 152 and expandable structure 153, as well as to removedevaporated cryogen from the bladder with an exit to the room. Thebladder formed by paddle structure 152 and expandable structure 153 isconfigured as cryogenic evaporation chamber, and the outer surface ofexpandable structure 153 is configured as a cryo-ablation surface.Expandable structure 153 is configured apply a force against the middlemeatus of the lateral nasal wall between approximately, e.g. 20 gramsand 200 grams. Expandable structure 153 is configured for expansion inreaction cryogen evaporation within. Liquid cryogen is introduced intothe bladder through probe shaft 154, and evaporated cryogen gas isremoved from the bladder and vented to the room trough probe shaft 154.The cryogenic ablation mechanisms and other features are similar tocryo-ablation probe embodiments described above and below.

FIGS. 11A and 11B are schematic illustrations of the distal end 166 ofpaddle porous balloon probe 163, which is an alternative embodiment ofpaddle balloon probe 150. FIG. 11 A is front view illustration, and FIG.11B is a side view illustration. Paddle porous balloon probe 163comprises probe shaft 167, porous expandable structure 165, and paddlestructure 164. Porous expandable structure 165 is similar to expandablestructure 153, described above, comprising a porous membrane versus anair tight membrane. Porous expandable structure 165 is configured forthe venting of evaporated cryogen gas through the pores 168 from withinthe bladder formed by porous expandable structure 165 and paddlestructure 164 into the patient's nostril in the immediate vicinity ofthe surface of the lateral nasal wall that is targeted forcryo-ablation. Venting the cold gas in the vicinity of the targetedlateral nasal wall enhances cooling effectiveness, while precluding theneed to vent the evaporated cryogen gas through probe shaft 167,allowing the probe shaft to be smaller in caliber, and therefore lesstraumatic. The cryogenic ablation mechanisms and other features aresimilar to cryo-ablation probe embodiments described above and below.

FIGS. 12A thru 12D are schematic illustrations of the distal end 179 ofdouble balloon paddle probe 178. FIG. 12A is a front view illustrationof double balloon paddle probe 178 with expandable structure 181 in itsun-expanded state. FIG. 12B is a side view illustration of doubleballoon paddle probe 178 with expandable structure in its un-expandedstate. FIG. 12C is a front view illustration of double balloon paddleprobe 178 with expandable structure 181 in its expanded state. FIG. 12Dis a side view illustration of double balloon paddle probe 178 with itsexpandable structure 181 in its expanded state. Double balloon paddleprobe 178 comprises probe shaft 180, expandable structure 181, paddlestructure 182, liquid cryogen port 183, and cryogen gas exhaust port184. In this embodiment, expandable structure 181 encompasses paddlestructure 182 and comprises a single ostium 185, and an adhesive bond186 which forms an air tight seal of for expandable structure 181. Theconfiguration and function of this embodiment substantially similar tothe embodiment depicted in FIGS. 6A to 6H, with the difference being inthis embodiment a paddle structure 182 is encompassed by expandablestructure 181, versus a spring-like structure or a formed wire structureencompassed by an expandable structure as depicted in FIGS. 6A to 6H.Optionally, the distal inner edge of paddle structure 182 and be bondedto the interior of expandable structure 181 by adhesive bond 187.

FIGS. 13A through 13D are schematic sectional coronal illustrations ofthe nasal cavity depicting ablation probe 201 access to the middlemeatus 198 between the middle nasal turbinate 6 and inferior nasalturbinate 7. Ablation probe 201 is a generic representation any of theablation probes disclosed here within that utilize and expandablestructure. FIG. 13A depicts the thin edge of the distal end of ablationprobe 201 being inserted into the thin gap between middle nasalturbinate 6 and inferior nasal turbinate 7. FIG. 13B depicts the distalstructure of ablation probe 201 behind middle turbinate against themiddle meatus 198 in position for an ablation. FIG. 13C depicts theinitiation of ablation by activation of the flow of cryogenic liquidinto the expandable structure 203 resulting in the inflation of theexpandable structure 203 as shown. Please note, as depicted, theexpandable structure is most similar to that depicted in FIGS. 10 and11, but is not intended imply a preference for those embodiments overthe other embodiments disclosed here within. FIG. 13D depicts theablation zone 204 resulting from the application of a cryo-ablation ofbetween approximately, e.g. 20 to 300 seconds. Following ablation, theprobe may be removed following a thawing period that may be betweenapproximately, e.g. 20 to 30 seconds. As depicted the sphenopalatinebranch, comprising the sphenopalatine artery, sphenopalatine vein, andsphenopalatine nerve, and the sphenopalatine foramen are substantiallyencompassed by the zone of ablation 204. As previously described, andfurther described below, the targeted tissue may comprise otherlocations, including the proximity of accessory posterolateral nervesbounded by a sphenopalatine foramen superiorly, an inferior edge of aninferior turbinate inferiorly, a Eustachian tube posteriorly, or aposterior third of the middle and inferior turbinates anteriorly. Otheranatomical targets may include the pterygomaxillary fossa,sphenopalatine ganglion, or vidian nerve.

FIG. 14A is an internal lateral view of the nasal cavity showing target228 for ablation of the parasympathetic nervous function of middleturbinate 6. Ablation target 228 is directly over the posterior superiorlateral nasal branches 11 which innervate middle turbinate 6. Ablationtarget 228 may be circular as shown or non-circular, with a zone ofablative effect between 1 mm and 4 mm deep. FIG. 14B is an internallateral view of the nasal cavity showing target 246 for ablation ofparasympathetic nervous function of superior turbinate 5, middleturbinate 6, and inferior turbinate 7. Ablation target 246 is linier asshown and is directly over posterior inferior lateral nasal branch 10,which innervates inferior turbinate 7, posterior superior lateral nasalbranch 11 which innervates middle turbinate 6, and superior lateralnasal branch 12 which innervates superior turbinate 5. The depth ofablative effect is ideally between 1 mm and 4 mm deep. FIG. 14C is aninternal lateral view of the nasal cavity showing target 247 forablation of parasympathetic nervous function of superior turbinate 5,middle turbinate 6, and inferior turbinate 7. Ablation target 246 islinier and segmented as shown with ablation segments directly overposterior inferior lateral nasal branch 10, which innervates inferiorturbinate 7, posterior superior lateral nasal branch 11 which innervatesmiddle turbinate 6, and superior lateral nasal branch 12 whichinnervates superior turbinate 5. The depth of ablative effect is ideallybetween 1 mm and 4 mm deep. FIG. 2D is an internal lateral view of thenasal cavity showing target 248 for ablation of the parasympatheticnervous function of middle turbinate 6. Ablation target 228 is directlyover the posterior superior lateral nasal branches 11 which innervatemiddle turbinate 6. Ablation target 248 is oblong as shown andpositioned between middle turbinate 6 and inferior turbinate 7 as shown,with a zone of ablative effect between 1 mm and 4 mm deep.

FIG. 15A is a schematic illustration of cryosurgical probe 234configured for cryo-ablation of parasympathetic nervous function of anasal turbinate(s) comprising a spatula shaped cryosurgical tip 236.Cryosurgical probe 234 comprises handle 235, probe shaft 237cryosurgical tip 236 refrigerant cartridge cover 239, and refrigerantcontrol push button 238. Handle 235 may comprise a receptacle, notshown, for receiving a refrigerant filled cartridge, not shown, whichmay comprise liquid carbon dioxide, which is used for evaporativecryogenic cooling within cryosurgical probe tip 236. Alternatively, thecartridge may comprise a compressed cryogenic gas which may compriseargon or nitrous oxide which is used for Joule-Thompson effect cryogeniccooling within cryosurgical probe tip 236. Those skilled in the artcryosurgical instrumentation are familiar with means for configuringcryosurgical probe 234 for evaporative cryogenic cooling orJoule-Thompson effect cryogenic cooling according to this invention,therefore, further detailed description relating to cryosurgicaltechniques are not warranted. Refrigerant control push button 238 is inmechanical communication with a valve which is configured to open whenpush button 238 is depressed by the operator causing the cryogen withinthe cartridge to flow into cryosurgical probe tip 236 through a conduitwithin probe shaft 237. Handle 235 further comprises a venting means,not shown for exhausting the expanded cryogen into the atmosphere. Probeshaft 237 is between approximately 2 mm and 6 mm in diameter, with alength between approximately 4 cm and 10 cm. FIG. 15B defines a sectionview of the cryosurgical probe 234 cryosurgical tip 236. FIG. 15C is across sectional view of the cryosurgical probe 234 distal end comprisingprobe shaft 237, refrigerant delivery tube 253, and probe tip 236.Cryogen delivery tube 253 traverses the length of probe shaft 237 in acoaxial relationship and is in fluidic communication with the cryogencartridge in handle 235 through the cryogen control valve previouslydescribed. At the distal end of cryogen delivery tube 253 there is atleast one lateral fenestration configured to direct the release of thepressurized cryogen 256 from cryogen delivery tube 253 into expansionchamber 251 of cryosurgical tip 236 in the direction of cryo-ablationsurface 249 of cryosurgical tip 236. Cryo-ablation surface 249 issubstantially flat. The opposing surface 250 to ablation surface 249 maybe cylindrical as shown. By directing the release of cryogen towardsablation surface 249, ablation surface 249 achieves cryo-ablationtemperatures between approximately −20 to −200 degrees centigrade, andopposing surface 250 remains warmer. The expanded cryogen 255 exitsexpansion chamber 251 through probe shaft 252 and is vented toatmosphere through handle 235 as previously described. Probe shaft 237,cryogen delivery tube 253, and cryosurgical tip 236 may fabricated froma stainless steel as is typical with cryosurgical probes, or may befabricated with alternative materials as is familiar to those skilled inthe art of cryosurgical probes. Probe shaft 237 may configured as shownwith curvatures configured for nasal anatomy, or alternatively may beconfigured as described below.

FIG. 16A is a schematic illustration of the distal end of an alternativeembodiment 262 of the cryosurgical probe comprising a bullet shapedcryo-ablation element at the distal end of angled probe shaft 265. Inthis embodiment pressurized cryogen is released through an orifice in anaxial direction into the expansion chamber in the directioncryo-ablation surface 264. The diameter of shaft 265 is betweenapproximately 2 mm and 6 mm, and the angle of shaft 265 is betweenapproximately 30 and 60 degrees, and the point of bend is between 1 cmand 3 cm from the distal end of ablation element 263. FIG. 16B is aschematic illustration of the distal end of an alternative embodiment266 of the cryosurgical probe comprising a bullet shaped cryo-ablationelement 263 at the distal end of a user deflectable probe shaft 267.Deflectable probe shaft 267 comprises distal deflectable segment 268 anda substantially rigid non-deflectable proximal segment 269. Probe shaft267 diameter is between approximately 2 mm and 6 mm. The border betweendeflectable distal segment 268 and proximal non-deflectable segment isbetween approximately 1 cm and 3 cm from the distal end of ablationelement 263. The angle of deflection may be between approximately 60 to120 degrees and may be configured for deflection in one direction, or intwo directions as shown. The deflection means comprises at least onepull wire housed within probe shaft 267 and a deflection actuatordisposed in the vicinity of the proximal end of probe 266. Those skilledin the art deflectable tipped surgical probes are familiar means forcreating a deflectable tipped cryosurgical probe according to thisinvention. FIGS. 16C and 16D are schematic illustrations of the distalend of an alternative embodiment 270 of the cryosurgical probe where thecryo-ablation element 274 is configured for producing multiple discretecryo-ablations simultaneously. Cryo ablation element 274 comprises anexpansion chamber, not shown, discrete lateral cryo-ablation surfaces272, surrounded by thermal insulation 273. Ablation element 274comprises a hollow bullet shaped metallic structure with lateralprotrusions in the surface forming cryo-ablation surfaces 272, with athermal insulating material covering all remaining external surfaces ofablation element 274 as shown. As with cryo-surgical probe 234, cryogenis released from cryogen delivery tube in a lateral direction towardscryo-ablation surfaces 272.

FIG. 17A is a schematic illustration of the distal end of an alternativeembodiment 280 of the cryosurgical probe comprising a semi-circularcryo-ablation element 282. Cryo-ablation element 282 comprises acontinuation of probe shaft 281 formed in a semi-circle as shown. Withinthe semi-circular section cryogen delivery tube 283 comprises an arrayof lateral fenestration in the one axial direction relative tosemi-circular form, making the corresponding surface of the ablationelement 282 the cryo-ablation surface. FIG. 17B is a schematicillustration of the ablation 284 morphology in the nasal mucosa 288resulting from use of the semi-circular ablation element 282. The gap286 in the ablation provides blood perfusion to the mucosa encompassedby the ablation providing a reduction in tissue sloughing as the resultof the ablation, as well as a reduction in the chance of infection, anda reduction of patient discomfort. FIG. 17C is a schematic illustrationof the distal end of an alternative embodiment 287 of the cryosurgicalprobe comprising a spiraled cryo-ablation element.

FIG. 18A is a schematic illustration of cryo-ablation balloon probe 294configured for cryo-ablation of parasympathetic nervous function of anasal turbinate(s). Cryo-ablation balloon probe 294 comprises balloon295, probe shaft 296, cryogen delivery tube 297, with lateralfenestrations 298 disposed on the distal end of cryogen delivery tube297 within balloon 295 as shown. Cryo-ablation balloon probe 294 furthercomprises proximal hub 299 with cryogen exhaust port 299, cryogen supplyport 301. Probe shaft 296 may be rigid or flexible. Balloon 295functions as a cryogen expansion chamber for either a cryogenicevaporation cooling process or a Joules-Thompson effect cooling process.Pressurized cryogen 256 is delivered to the interior of balloon 295through cryogen delivery tube 297 under pressure. Cryogen 256 exitscryogen delivery tube 297 through lateral fenestrations 298 as shown, inthe radial direction towards the wall of balloon 295. The radial wall ofballoon 295 is the cryo-ablation surface. Expanded cryogen 255 exitsballoon 295 through probe shaft 296, and is vented to atmosphere throughexhaust port 300. Exhaust port 300 may comprise a pressure relief valve,which creates a back pressure to inflate balloon 295 at a predeterminedpressure. Cryogen supply port 301 is configured to connect cryogensupply tube 297 to a source of cryogen. Proximal hub 299 may beconfigured as a handle, and comprise a cryogen control valve. FIG. 18Bis a schematic illustration of the distal end of the cryo-ablationballoon probe detailing the geometry of the cryo-ablation balloon. Thelength 302 of balloon 295 is between approximately 3 mm and 20 mm, andthe diameter 303 of balloon 295 is between 1 mm and 5 mm. FIG. 18C is aschematic illustration of an alternate embodiment 304 of thecryo-ablation balloon probe 294 comprising an insulating chamber 307within the cryo balloon 305 structure. Insulating chamber 307 is formedby membrane 306 as shown. Fenestration 308 is a small opening incommunication between expansion chamber 311 and insulating chamber 307,which allows insulation chamber to inflate with expanded cryogen gas 255in a substantially static manner providing thermal insulation to thesurface of balloon 305 adjacent to insulation chamber 307. Lateralfenestrations 310 direct pressurized cryogen 301 towards the wall ofballoon 305 opposite of insulation chamber 307 forming cryo-ablationsurface 312. The length 302 of balloon 305 is between approximately 3 mmand 20 mm, and the diameter of balloon 305 is between approximately 1 mmand 6 mm. FIG. 18D is a schematic illustration of the distal end of analternative embodiment 313 of the cryo-ablation balloon probe 294comprising a tee shaped cryo-ablation balloon 314. The length 302 ofballoon 314 is between approximately 3 mm to 20 mm, and the diameter ofballoon 303 is between approximately 1 mm and 6 mm. Cryogen deliverytube 315 is configured to direct pressurized cryogen down the horns 316of balloon 314 as shown. FIG. 18E is a schematic illustration of thedistal end of an alternative embodiment 317 of the cryo-ablation balloonprobe 294 comprising a “J” shaped cryo-ablation balloon 318. The length302 of balloon 318 is between approximately 3 mm and 20 mm, and thediameter 303 of balloon 318 is between approximately 1 mm and 6 mm.Cryogen delivery tube 319 is configured to direct pressurized cryogen256 laterally into the “J” as shown.

FIG. 19A is a schematic illustration of the distal end of an alternateembodiment 325 of cryo-ablation probe 294 comprising a cryo-ablationelement 326 with suction stabilization. FIG. 19B is a cross sectionalview of the distal end of the alternative embodiment 325 showing theconfiguration of the cryo-ablation element 326 and the suctionstabilization means.

Ablation element 326 is surrounded by suction chamber 329 as shown.Suction chamber 329 is in fluidic communication with a suction source,not shown, by suction tube 331. Suction ports 330 are oriented in thesame direction as cryo-ablation surface 332 and are configured toprovide suction attachment to the tissue when cryo-ablation surface 332is placed into contact with the nasal mucosa in the ablation targetzone. Probe shaft 325, cryogen delivery tube 327, and lateralfenestrations 328 have similar function those previously described.

FIG. 20A is a schematic illustration of radiofrequency (RF) ablationprobe 338 configured for ablation of the parasympathetic nervousfunction of a nasal turbinate(s) with a bi-polar ring electrode ablationelement 342 on an “J” shaped distal probe tip 341. RF ablation probe 338comprises handle 339, probe shaft 340, “J” shaped probe tip 341, bipolarring electrode pair 342, RF activation switch 345, electrical connector343, and fluid connector 344. Those skilled in the art of RF ablationprobes are familiar with the many possible configurations andconstruction techniques for RF electrodes and probes that are within thescope of this invention, therefore detailed description of theillustrated electrode configurations described below, and theirconstruction techniques is not warranted. Electrical connector 343 isconfigured for connection to a radiofrequency energy generator, forwhich there are many commercially available. Fluid connector 344 isconfigured for connection to source of liquid irrigant. Fluid connector344 may be in fluidic communication with at least one fluid irrigationport located the vicinity of the RF ablation electrode, and isembodiment specific. RF activation switch 345 allows the user toactivate the RF ablation and terminate the RF ablation. Probe shaft 340is between approximately 2 mm to 6 mm in diameter, and betweenapproximately 4 cm and 10 cm long, but could be longer. The length of“J” tip 341 is between approximately 0.5 cm and 1.5 cm. Ring the spacingbetween RF electrode pair 342 is between approximately 2 mm and 6 mm.FIG. 20B is a schematic illustration of the distal end of an alternativeembodiment 346 of RF ablation probe 338 comprising a bi-polar segmentedring electrode ablation element on an “J” shaped distal probe shaft. Thegap 348 shown in the ring electrode is on the side opposite of the sideconfigured for RF ablation. The gap 348 in the ring electrodes protectthe nasal septum during RF ensuring that RF energy is only applied tothe lateral nasal wall at the ablation target. FIG. 20C is a schematicillustration of alternative embodiment 349 of the distal end of RFablation probe 338 comprising a bi-polar electrode ablation element 350on a “J” shaped distal probe shaft with the electrodes disposed in alateral array. FIG. 20D is a schematic illustration of alternativeembodiment 351 of the distal end of RF ablation probe 338 comprising abi-polar electrode ablation element 352 on a “U” shaped distal probeshaft 353 with the electrodes disposed in a lateral array. FIG. 20E is aschematic illustration of the distal end of alternative embodiment 354of RF ablation probe 338 comprising a bi-polar electrode ablationelement 355 on a user deployable “T” shaped structure 356. Element 356is comprised of two halves which can alternately be collapsed anddeployed as in FIG. 20E. The two halves of the electrode structure 356are pivoted to allow them to move laterally relative to the cathetershaft 354. Electrodes 355 can operate in a mono polar, bipolar ormultipolar fashion as known in the art.

FIG. 21A is a schematic illustration of alternative embodiment 362 to RFablation probe 338 configured for ablation of the parasympatheticnervous function of a nasal turbinate(s) comprising an array of RFablation electrodes 363 disposed on a planar surface with a fluidirrigation means associated with the electrodes. FIG. 21B is a schematicillustration of the distal end of the RF ablation probe 362 showing thearrangement of the ablation electrode array 363 and the associated fluidirrigation means. Alternative embodiment 362 comprises distal probe tip119, probe shaft 369, handle 339, fluid connector 344, and electricalconnector 343. Electrode array 363 comprises two or more dome shapedelectrodes 365, that are electrically configured into a bipolar pair,meaning that if there are 4 electrodes 365, then two of the electrodesare connectable to one pole of an RF generator, and the second twoelectrodes are connectable to the opposite pole of the RF generator,etc. Electrodes 365 are dome shaped and protrude from planar surface366. A fluid port 364 is associated with each electrode 365. All fluidports are in fluidic communication with fluid connector 344. Fluid ports364 are configured to irrigate the surface of the nasal mucosa that iscontact with electrodes 365 to provide cooling of the mucosa and theelectrodes 365, to minimize thermal injury to the surface of the mucosa,and to prevent sticking of the electrodes to the surface of the mucosa.Probe tip 371 is between approximately 4 mm and 8 mm in diameter, andbetween approximately 3 mm to 8 mm thick. The number of electrodes 365of electrode array 363 may be between 2 and approximately 10.

FIG. 22A is a schematic illustration of an alternative embodiment 377 ofRF ablation probe 362 comprising a linear electrode array 378 disposedon a planar surface; a fluid irrigation ports 387 associated electrodes379, and a deployable needle 380 configured for injecting a liquid intoa sub-mucosal space. FIG. 22B is a schematic illustration of the distalend of the alternative embodiment 377 RF ablation probe showing thearrangement of the ablation electrodes 379 and the associated fluidirrigation ports 387. FIG. 22C is a schematic illustration of the distalend of the alternative embodiment 377 RF ablation probe showing thearrangement of the ablation electrodes 379 and the associated fluidirrigation ports 387 with the needle 380 deployed. The function, ofdomed electrodes 379, fluid ports 387, electrical connector 343, fluidconnector 344, RF activation switch 345, handle 382, and shaft 384 allfunction in essentially the same manner as described for priorembodiment 362. This embodiment has a linear electrode array 378, and adeployable needle configured for injecting a liquid into the sub-mucosalspace where the liquid may comprise an anesthetic. Needle actuator 383provides the user a means actuating needle 380. Fluid connector 389 isin fluidic communication with needle 380, through needle shaft 385, andis configured with a female luer connector for mating with a syringe,not shown. Shaft 384 contains needle shaft 385, electrical cable 386,and provides a conduit for irrigation fluid, not shown.

FIG. 23A is a schematic illustration of an RF interstitial needleablation probe 395 configured for interstitial ablation of a posteriornasal nerve. FIG. 23B is a schematic illustration of the distal end 396of the RF interstitial needle ablation probe 395. RF interstitial needleprobe 395 comprises distal tip 396, probe shaft 398, handle 399,electrical connector 400, fluid connector 401, RF activation switch 402.Distal tip 396 comprises interstitial needle electrode array 397, whichcomprises more than one interstitial needle 464 Handle, 399, RFactivation switch 402, electrical connector 400, and probe shaft 398function in a manner previously described. Fluid port 401 is in fluidiccommunication with at least one RF ablation needle 464, with the atleast one RF ablation needle 464 being hollow and configured forinjecting a liquid into the nasal sub-mucosal space. Each RF ablationneedle 464 has a proximal electrically insulating coating 405, and adistal electrically insulating coating 404, forming RF electrode surface403. Proximal insulator 405, and distal insulator 404 are configured forlimiting the ablation effects to the sub-mucosal space, which will bedescribed in further detail below. Interstitial needle electrode array397 may be configured as a mono-polar electrode array, or a bipolarelectrode array. Interstitial needle electrode array 397 may beconfigured as a linear array, a circular array, a triangular array, orany other geometric form. Interstitial needle electrode array 397 maycomprise two or more RF ablation needles 464. RF ablation needles 464are between approximately 18 and 28 gauge, and between approximately 3mm and 10 mm long.

FIG. 24A is a cross sectional view of the distal end of an alternativeembodiment 411 to RF interstitial needle ablation probe 395 comprising adeployable and retractable array of RF ablation needles 412 configuredfor lateral deployment showing the needle array retracted. FIG. 24B is across sectional view of the distal end of an alternative embodiment 411of RF interstitial needle ablation probe 395 comprising a deployable andretractable array of RF ablation needles configured for lateraldeployment showing the needle array deployed. Interstitial needle array412 is housed in a hollow sheath with a “J” tip 413 as shown. Linearactuator shaft 414 is in mechanical communication with a user actuatorlever at the proximal end not shown. Linear actuator shaft 414 is movedin the distal direction to deploy needle array 412, and moved in theproximal direction to retract needle array 412 as shown. FIG. 24C is across sectional view of the distal end of an alternative embodiment 415of RF interstitial needle ablation probe 395 comprising a deployable andretractable array of RF ablation needles configured for axial deploymentshowing the needle array retracted. FIG. 24D is a cross sectional viewof the distal end of an alternative embodiment 415 of RF interstitialneedle ablation probe 395 comprising a deployable and retractable arrayof RF ablation needles configured for axial deployment showing theneedle array deployed.

FIG. 25A is a schematic illustration of an integrated flexible circuit421 configured for use with an RF ablation probe comprising an RF energysource and control circuits 422 at one end, and an RF ablation electrodearray 423 at the opposite end, connected by electrical conduits 426.FIG. 25B is a schematic illustration of the RF ablation electrode array423 of the flexible circuit mounted on the distal shaft of an RFablation probe that is configured for ablation of the parasympatheticnervous function of a nasal turbinate. Also shown are optional fluidports associated with the RF ablation electrode array as shown, withirrigation fluid 427 supplied to irrigation ports 425 through distalshaft 424.

FIG. 26A is an in situ schematic illustration of the RF ablation probe377 depicted in FIGS. 10 through 10C showing needle 380 injecting ananesthetic into the sub-mucosal space 433 prior to an RF ablation of theposterior nasal nerve 434. FIG. 26B is an in situ schematic illustrationof the resulting RF ablation 436 showing the ablation zone 436encompassing posterior nasal nerve 434, and residing below the mucosalsurface 437 due to the cooling effect of liquid irrigant 435.

FIG. 27 is an in situ schematic illustration of an RF ablation of theparasympathetic nerve of a posterior nasal nerve 434 using the RFinterstitial needle ablation probe 395 depicted in FIGS. 11A and 11Bshowing ablation zone 436 encompassing posterior nasal nerve 434 andresiding below the mucosal surface 437 due to the arrangement of needleelectrode surface(s) 403 and needle insulation zones 404 & 405.

FIG. 28 is an in situ illustration of the ablation of the posteriornasal nerve depicted in FIG. 14D. Generic ablation device 441 is shownwith cylindrical ablation element 442, which could be a cryo ablationelement, an RF ablation element, or some other type of thermal ablationelement. Also shown is endoscope 443, which provides the surgeon animage for positioning ablation element 442 at the target location, and ameans for monitoring the ablation.

FIG. 29 is an in situ illustration of the ablation of the posteriornasal nerve of a nasal turbinate at the ablation target depicted in FIG.14B. Generic ablation device 441 is shown with cylindrical ablationelement 442, which could be a cryo ablation element, an RF ablationelement, or some other type of thermal ablation element. Also shown isendoscope 443, which provides the surgeon an image for positioningablation element 442 at the target location, and a means for monitoringthe ablation.

FIG. 30 is an in situ illustration of the ablation of the posteriornasal nerve using a generic “T” tipped ablation device 448. Generic “T”tipped ablation device 448 is shown with ablation elements 449, whichcould be cryo ablation elements, RF ablation elements, or some othertype of thermal ablation elements. Also shown is endoscope 443, whichprovides the surgeon an image for positioning ablation element 442 atthe target location, and a means for monitoring the ablation.

FIG. 31A is a schematic illustration of generic ablation probe 455 andan insulated probe guide 457 configured to protect the nasal septum fromthermal injury during an ablation of the parasympathetic nervousfunction of a nasal turbinate(s). Probe guide 457 is configured to pressablation element 456 of probe 455 against the lateral wall of a nasalcavity 458 and create a thermally insulative space between the lateralwall of the nasal cavity 458 and the nasal septum 459 as shown in FIGS.31B and 31C. Probe guide 457 may be fabricated from foam material, orany other suitable thermally insulative material. FIG. 31B is an in situillustration of generic ablation probe 437 configured for ablation ofthe posterior nasal nerve which comprises an insulating structure 460configured to protect the nasal septum 459 from thermal injury.Structure 460 may comprise an inflatable balloon. FIG. 31C is an in situillustration of generic ablation probe 455 configured for ablation ofthe parasympathetic nervous function of a nasal turbinate(s) whichcomprises a space creating structure 461 configured to protect the nasalseptum 459 from thermal injury. Structure 461 may comprise a deployablewire structure or surgical basket structure.

What is claimed is:
 1. A method for treating a tissue region within anasal cavity, comprising: advancing a distal end of a surgical probeshaft through the nasal cavity and into proximity of the tissue regionhaving at least one posterior nasal nerve; introducing a cryogenic fluidinto an expandable structure coupled to the distal end of the probeshaft such that the expandable structure inflates from a deflatedconfiguration into an expanded configuration against the tissue region,wherein the cryogenic fluid evaporates within the expandable structure;adjusting a position of a member relative to the tissue region, whereinthe member is disposed at to the distal end of the probe shaft andextends within the expandable structure which encloses the member suchthat the member is unattached to an interior of the expandablestructure; applying a pressure against the tissue region having the atleast one posterior nasal nerve via the member pressing against theinterior of the expandable structure, wherein the member defines anatraumatic shape which is sized for pressing against and manipulatingthe tissue region through the expandable structure; and maintaining themember against the interior of the expandable structure and the tissueregion until the tissue region is cryogenically ablated.
 2. The methodof claim 1 wherein the maintaining the member further comprisescryogenically ablating the at least one posterior nasal nerve untilsymptoms of rhinitis are reduced.
 3. The method of claim 1 wherein theadvancing the distal end comprises advancing the distal end through anostril and into the nasal cavity.
 4. The method of claim 1 wherein theadvancing the distal end comprises advancing the distal end at least 2cm beyond an anterior entrance to a middle meatus.
 5. The method ofclaim 1 wherein the advancing the distal end comprises: advancing thedistal end along an upper surface of the inferior nasal turbinate to amid-portion of the middle nasal turbinate; advancing the distal end intoa middle meatus; and further advancing the distal end posteriorly upinto a cul-de-sac.
 6. The method of claim 1 wherein the advancing thedistal end comprises positioning the member between the middle andinferior nasal turbinate.
 7. The method of claim 1 wherein the advancingthe distal end comprises positioning the member relative to the tissueregion surrounded by the middle nasal turbinate, inferior nasalturbinate, and lateral wall forming a cul-de-sac.
 8. The method of claim1 wherein the advancing the distal end comprises positioning the memberinto proximity of the Pterygomaxillary fossa, sphenopalatine ganglion,sphenopalatine ganglion, or vidian nerve.
 9. The method of claim 1wherein the advancing the distal end comprises positioning the memberinto proximity of accessory posterolateral nerves bounded by ansphenopalatine foramen superiorly, an inferior edge of an inferiorturbinate inferiorly, a Eustachian tube posteriorly, or a posteriorthird of the middle and inferior turbinates anteriorly.
 10. The methodof claim 1 wherein the introducing the cryogenic fluid further comprisesexpanding the expandable structure to a greater extent in one radialaxis compared to a second radial axis.
 11. The method on claim 1 whereinthe adjusting the a position of the member further comprises positioningthe member to contact a lateral nasal wall defined by a tail of a nasalturbinate, lateral wall, and an inferior turbinate.
 12. The method ofclaim 1 wherein the introducing the cryogenic fluid further comprisesflowing the cryogenic fluid into the interior between approximately 20seconds to 300 seconds.
 13. The method of claim 1 wherein theintroducing the cryogenic fluid further comprises flowing the cryogenicfluid into the interior between approximately 20 seconds to 120 seconds.14. The method of claim 1 wherein the cryogenic fluid comprises nitrousoxide, liquid nitrogen, or carbon dioxide.
 15. The method of claim 1further comprising positioning an imaging device in proximity to thedistal end of the surgical probe shaft.
 16. The method of claim 1further comprising visualizing the tissue region while the surgicalprobe shaft is advanced through the nasal cavity.
 17. The method ofclaim 16 wherein the visualizing is carried out via a CCD or CMOS imagerpositioned along the surgical probe shaft.
 18. The method of claim 16wherein the visualizing comprises visualizing infrared wavelengths. 19.The method of claim 16 wherein the visualizing is carried out via anasal endoscope.
 20. The method of claim 19 wherein the visualizingcomprises advancing the nasal endoscope with the surgical probe shaft.21. The method of claim 1 further comprising introducing a temperaturesensor in proximity to the distal end of the surgical probe shaft. 22.The method of claim 1 wherein the advancing the distal end comprisespositioning the surgical probe shaft into proximity of an anteriorregion of middle or inferior nasal turbinate.
 23. The method of claim 1wherein the applying the a pressure comprises applying a force of 20 to200 grams via the member pressing against the interior of the expandablestructure.
 24. The method of claim 1 further comprising stopping thecryogenic fluid and waiting 10 to 20 seconds prior to removing thedistal end of the surgical probe shaft from the tissue region.
 25. Themethod of claim 1 wherein the maintaining the member comprises ablatingthe tissue region through a layer of gel.
 26. The method of claim 1further comprising assessing the tissue region during and/or afterablation.
 27. The method of claim 26 wherein the assessing comprisesinspecting the tissue region visually or via ultrasound.
 28. The methodof claim 26 wherein the assessing comprises detecting of a temperatureof the tissue region.
 29. The method of claim 1 further comprisingvibrating the expandable structure while maintaining the member againstthe interior of the expandable structure and the tissue region.
 30. Themethod of claim 1 further comprising applying an anesthetic to thetissue region to be treated prior to applying a pressure against thetissue region.
 31. A method for treating a tissue region within a nasalcavity, comprising: advancing a distal end of a surgical probe shaftthrough the nasal cavity and into proximity of the tissue region havingat least one posterior nasal nerve; introducing a cryogenic fluid intoan expandable structure coupled to the distal end of the probe shaftsuch that the expandable structure inflates from a deflatedconfiguration into an expanded configuration against the tissue region,wherein the expandable structure is inflated in response to evaporationof the cryogenic fluid within an interior of the expandable structure;adjusting a position of a member relative to the tissue region, whereinthe member is disposed at the distal end of the probe shaft and extendswithin the expandable structure which encloses the member such that themember is unattached to the interior of the expandable structure;applying a pressure against the tissue region having the at least oneposterior nasal nerve via the member pressing against the interior ofthe expandable structure, wherein the member defines an atraumatic shapewhich is sized for pressing against and manipulating the tissue regionthrough the expandable structure; and maintaining the member against theinterior of the expandable structure and the tissue region until thetissue region is cryogenically ablated.
 32. A method for treatingrhinitis, comprising: advancing a distal end of a surgical probe shaftthrough the nasal cavity and into proximity of a tissue regionsurrounded by the middle nasal turbinate, inferior nasal turbinate, andlateral wall forming a cul-de-sac and having at least one posteriornasal nerve; introducing a cryogenic fluid into an expandable structurecoupled to the distal end of the probe shaft such that the expandablestructure inflates from a deflated configuration into an expandedconfiguration against the tissue region, wherein the distal end has amember which extends within the expandable structure such that themember is unattached to the interior of the expandable structure,wherein the expandable structure is inflated in response to evaporationof the cryogenic fluid within an interior of the expandable structure;applying a pressure against the tissue region via the member pressingagainst the interior of the expandable structure, wherein the memberdefines an atraumatic shape; and maintaining the member against theinterior of the expandable structure and the tissue region until thetissue region is cryogenically ablated.
 33. A method for treatingrhinitis, comprising: advancing a distal end of a surgical probe shaftthrough the nasal cavity and into proximity of a tissue regionsurrounded by the middle nasal turbinate, inferior nasal turbinate, andlateral wall forming a cul-de-sac and having at least one posteriornasal nerve; introducing a cryogenic fluid into an expandable structurecoupled to the distal end of the probe shaft such that the expandablestructure inflates from a deflated configuration into an expandedconfiguration against the tissue region, wherein the distal end has amember which extends within the expandable structure such that themember is unattached to the interior of the expandable structure,wherein the cryogenic fluid evaporates within the expandable structure;applying a pressure against the tissue region via the member pressingagainst the interior of the expandable structure, wherein the memberdefines an atraumatic shape and is unattached to the interior of theexpandable structure; and maintaining the member against the interior ofthe expandable structure and the tissue region until the tissue regionis cryogenically ablated.
 34. The method of claim 33 wherein theadvancing the distal end comprises advancing the distal end at least 2cm beyond an anterior entrance to a middle meatus.
 35. The method ofclaim 33 wherein the advancing the distal end comprises: advancing thedistal end along an upper surface of the inferior nasal turbinate to amid-portion of the middle nasal turbinate; advancing the distal end intoa middle meatus; and further advancing the distal end posteriorly upinto a cul-de-sac.
 36. The method of claim 33 wherein the advancing thedistal end comprises positioning the member between the middle andinferior nasal turbinate.
 37. The method of claim 33 wherein theadvancing the distal end comprises positioning the member into proximityof the Pterygomaxillary fossa, sphenopalatine ganglion, sphenopalatineganglion, or vidian nerve.
 38. The method of claim 33 wherein theadvancing the distal end comprises positioning the member into proximityof accessory posterolateral nerves bounded by an sphenopalatine foramensuperiorly, an inferior edge of an inferior turbinate inferiorly, aEustachian tube posteriorly, or a posterior third of the middle andinferior turbinates anteriorly.
 39. The method on claim 33 wherein theadvancing the distal end further comprises positioning the member tocontact a lateral nasal wall defined by a tail of a nasal turbinate,lateral wall, and an interior turbinate.
 40. The method of claim 33wherein the introducing the cryogenic fluid comprises flowing thecryogenic fluid into the interior between approximately 20 seconds to300 seconds.
 41. The method of claim 33 wherein the introducing thecryogenic fluid further comprises flowing the cryogenic fluid into theinterior between approximately 20 seconds to 120 seconds.
 42. The methodof claim 33 wherein the cryogenic fluid comprises nitrous oxide, liquidnitrogen, or carbon dioxide.
 43. The method of claim 33 furthercomprising positioning an imaging device in proximity to the distal endof the surgical probe shaft.
 44. The method of claim 33 furthercomprising visualizing the tissue region while the surgical probe shaftis advanced through the nasal cavity.
 45. The method of claim 44 whereinthe visualizing is carried out via a CCD or CMOS imager positioned alongthe surgical probe shaft.
 46. The method of claim 44 wherein thevisualizing comprises visualizing infrared wavelengths.
 47. The methodof claim 44 wherein the visualizing is carried out via a nasalendoscope.
 48. The method of claim 47 wherein the visualizing comprisesadvancing the nasal endoscope with the surgical probe shaft.
 49. Themethod of claim 33 further comprising introducing a temperature sensorin proximity to the distal end of the surgical probe shaft.
 50. Themethod of claim 33 wherein the applying the pressure comprises applyinga force of 20 to 200 grams via the member pressing against the interiorof the expandable structure.
 51. The method of claim 33 furthercomprising stopping the cryogenic fluid and waiting 10 to 20 secondsprior to removing the distal end of the surgical probe shaft from thetissue region.
 52. The method of claim 33 wherein the maintaining themember comprises ablating the tissue region through a layer of gel. 53.The method of claim 33 further comprising assessing the tissue regionduring and/or after ablation.
 54. The method of claim 53 wherein theassessing comprises inspecting the tissue region visually or viaultrasound.
 55. The method of claim 53 wherein the assessing comprisesdetecting a temperature of the tissue region.
 56. The method of claim 33further comprising vibrating the expandable structure while maintainingthe member against the interior of the expandable structure and thetissue region.
 57. The method of claim 33 further comprising applying ananesthetic to the tissue region to be treated prior to applying apressure against the tissue region.